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    Clinical Trial Results:
    Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - A prospective, double-blind, multicentre, randomised control trial

    Summary
    EudraCT number
    2010-022894-32
    Trial protocol
    GB  
    Global end of trial date
    16 Feb 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Nov 2019
    First version publication date
    11 Nov 2019
    Other versions
    Summary report(s)
    Dreams trial final report_signature page
    DREAMS End Of Trial Report_Feb 2016

    Trial information

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    Trial identification
    Sponsor protocol code
    RG_10-209
    Additional study identifiers
    ISRCTN number
    ISRCTN21973627
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    The University of Birmingham
    Sponsor organisation address
    Edgbaston, Birmingham, United Kingdom,
    Public contact
    Laura Magill, The University of Birmingham, 0044 1214159105, e.l.magill@bham.ac.uk
    Scientific contact
    Laura Magill, The University of Birmingham, 0044 1214159105, e.l.magill@bham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The DREAMS trial is a 2 stage study: i) a feasibility study and ii) a phase IV randomsied controlled trial. The objective of the feasibility study is to assess the feasibility of running the phase IV study. This pilot trial will develope effective strategies for patient identification, recruitment and follow-up in the main part of the trial. The objective of the full trial is to determine whether dexamethasone reduces postoperative nausea and vomiting in patients undergoing planned major bowel surgery and to determine it's role in future use in this category of patients.
    Protection of trial subjects
    Dexamethasone is a safe and widely used drug for the purpose of reducing PONV. It is widely, but not universally used, for patients undergoing abdominal surgery. As the use of the drug in reducing PONV had not previously been studied specifically in patients undergoing bowel surgery, the DREAMS trial aimed to assess that. Patients allocated to receive dexamethasone were administered a single IV dose of pre-operative dexamethsone. The adverse affects of dexamethsone are well characterised and include gastrointestinal disturbances, hyperglycaemia, wound infection, wound dehiscence and anastomotic leak. All adverse effects were monitored and reported. Patients at increased risk of dexamethasone related adverse effects were excluded from this study.
    Background therapy
    One other anti-emetic which all pateints were meant to have - LM to add
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Jul 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1350
    Worldwide total number of subjects
    1350
    EEA total number of subjects
    1350
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    631
    From 65 to 84 years
    690
    85 years and over
    29

    Subject disposition

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    Recruitment
    Recruitment details
    The first patient was recruited and randomised on 17-Jul-2011 and the last patient was randomised into the trial on 31-Jan-2014. 1350 patients were recruited from 48 centres in the UK. Of these patients, 674 were entered into the Dexamethasone arm (the intervention arm) and 676 patients in the no dexamethasone arm (control arm).

    Pre-assignment
    Screening details
    Of the 2894 patients assessed for eligibility, 1544 patients were excluded prior to randomisation, therefore 1350 patients were randomised into the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor
    Blinding implementation details
    The randomised treatment allocation was given to the anaesthetist (or a member of their team). This randomisation allocation was not entered on the anaesthetic chart, operation record or patient notes. Dexamethasone was not prescribed nor its administration recorded on the anaesthetic or drug chart, instead, stickers were provided in the DREAMS site file which were added to the patient notes to explain that the patient is in a blinded trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dexamethasone
    Arm description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the intervention treatment arm was: 8 mg IV dexamethasone (plus one other anti-emetic of the anaesthetist’s choice) following induction of anaesthesia but prior to commencement of surgery.
    Arm type
    Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The active compound of dexamethasone is Dexamethasone Sodium Phosphate. Dexamethasone administered within the trial is from standard NHS hospital stock. There are two dexamethasone preparations available for parenteral use in the UK. In line with MHRA-guidance, changes to the labelling were made in 2010 so that both preparations are labelled to reflect the amount of dexamethasone base per volume; the two products remain different concentrations. It is now recommended that parenteral dexamethasone is prescribed as dexamethasone base, for trial purposes 8mg dexamethasone base should be given. As dexamethasone comes in two forms of 4mg/ml and 3.3mg/ml, the anaesthetist/research investigator administering the drug will draw up the accurate volume to make up 8mg (2ml from the 4mg/ml vial and 2.4ml from the 3.3mg/ml vial).

    Arm title
    no Dexamethasone
    Arm description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the control arm was induction of anti-emetic of the anaesthetist’s choice (not dexamethasone) prior to commencement of surgery.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Dexamethasone no Dexamethasone
    Started
    674
    676
    Completed
    674
    676

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the intervention treatment arm was: 8 mg IV dexamethasone (plus one other anti-emetic of the anaesthetist’s choice) following induction of anaesthesia but prior to commencement of surgery.

    Reporting group title
    no Dexamethasone
    Reporting group description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the control arm was induction of anti-emetic of the anaesthetist’s choice (not dexamethasone) prior to commencement of surgery.

    Reporting group values
    Dexamethasone no Dexamethasone Total
    Number of subjects
    674 676 1350
    Age categorical
    Units: Subjects
        <50
    91 97 188
        50-59
    128 120 248
        60-69
    214 223 437
        70-79
    189 172 361
        >=80
    52 64 116
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.6 ± 13.4 63.4 ± 13.5 -
    Gender categorical
    Units: Subjects
        Female
    283 284 567
        Male
    391 392 783
    Smoking status
    Units: Subjects
        non-smoker
    574 576 1150
        smoker
    100 100 200
    ASA grade
    The ASA grade for all patients was collecetd at trial entry. ASA grade was a stratification variable.
    Units: Subjects
        P1
    157 155 312
        P2
    402 405 807
        P3
    113 113 226
        P4
    2 3 5
    abdominal access
    Units: Subjects
        laparoscopic
    429 427 856
        open
    245 249 494
    Enhanced recovery after surgery programme
    Units: Subjects
        Yes
    611 615 1226
        No
    54 53 107
        not known
    9 8 17
    duration of anesthesia categorical
    Units: Subjects
        <60 minutes
    5 10 15
        60-119 minutes
    55 56 111
        120-239 minutes
    333 312 645
        >=240 minutes
    277 294 571
        missing
    4 4 8
    type of surgery
    Units: Subjects
        stoma formation
    8 9 17
        stoma reversal
    66 76 142
        small bowel surgery
    7 9 16
        right colon resection
    150 153 303
        left/sigmoid colon resection
    122 99 221
        subtotal/total colectomy
    27 22 49
        rectal resection
    276 297 573
        other
    17 9 26
        missing
    1 2 3
    post operative analgesia
    Units: Subjects
        epidural
    307 308 615
        PCA
    238 238 476
        not known
    68 70 138
        other
    50 49 99
        none
    11 11 22
    duration of anesthesia continuous
    Units: minutes
        arithmetic mean (standard deviation)
    226 ± 99 226 ± 108 -

    End points

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    End points reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the intervention treatment arm was: 8 mg IV dexamethasone (plus one other anti-emetic of the anaesthetist’s choice) following induction of anaesthesia but prior to commencement of surgery.

    Reporting group title
    no Dexamethasone
    Reporting group description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the control arm was induction of anti-emetic of the anaesthetist’s choice (not dexamethasone) prior to commencement of surgery.

    Primary: vomiting within 24 hours post-surgery (24 hours)

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    End point title
    vomiting within 24 hours post-surgery (24 hours)
    End point description
    End point type
    Primary
    End point timeframe
    Primary outcome: proportion of patients who expereinced vomiting was measured within the first 24 hours post-surgery.
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    674
    676
    Units: subjects
        Yes
    172
    223
        No
    502
    453
    Statistical analysis title
    primary outcome - vomiting by 24 hours
    Statistical analysis description
    chi squared test: proportion of patients experiencing vomiting within first 24 hours
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0026
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.7736
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.654
         upper limit
    0.915

    Secondary: vomiting between 25-72 hours post-surgery (24 hours)

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    End point title
    vomiting between 25-72 hours post-surgery (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-surgery
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    674
    676
    Units: subjects
        yes
    227
    254
        no
    447
    422
    Statistical analysis title
    vomiting between 25-72 hours
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1352
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.8964
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7763
         upper limit
    1.0349

    Secondary: vomiting between 73-120 hours post-surgery (24 hours)

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    End point title
    vomiting between 73-120 hours post-surgery (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-surgery
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    674
    676
    Units: subjects
        yes
    152
    150
        no
    522
    526
    Statistical analysis title
    vomiting between 73-120 hours
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.873
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.0163
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8332
         upper limit
    1.2398

    Secondary: patient reported clinically important PONV (24 hours)

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    End point title
    patient reported clinically important PONV (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    631
    624
    Units: subjects
        Yes
    54
    79
        No
    577
    545
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1255
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.02
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.49
         upper limit
    0.94
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1255
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.02
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.5
         upper limit
    -0.7

    Secondary: patient reported vomiting/retching (24 hours)

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    End point title
    patient reported vomiting/retching (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    652
    652
    Units: subjects
        Yes
    158
    212
        No
    494
    440
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1304
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.63
         upper limit
    0.89
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1304
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -8.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.2
         upper limit
    -3.4

    Secondary: patient reported nausea (24 hours)

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    End point title
    patient reported nausea (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    650
    650
    Units: subjects
        Yes
    262
    324
        No
    388
    326
    Statistical analysis title
    Risk Ratio
    Comparison groups
    no Dexamethasone v Dexamethasone
    Number of subjects included in analysis
    1300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.91
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -9.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.9
         upper limit
    -4.2

    Secondary: patient reported nausea - VAS scale (24 hours)

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    End point title
    patient reported nausea - VAS scale (24 hours)
    End point description
    higher values indicate higher levels of nausea
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    251
    304
    Units: subjects
        arithmetic mean (standard deviation)
    37.8 ± 26.6
    41.7 ± 28.0
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    555
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.09
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.5
         upper limit
    0.7

    Secondary: return to any oral diet (24 hours)

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    End point title
    return to any oral diet (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    673
    672
    Units: subjects
        Yes
    654
    644
        No
    19
    28
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.99
         upper limit
    1.03
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.6
         upper limit
    3.3

    Secondary: return to oral diet (fluids only) (24 hours)

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    End point title
    return to oral diet (fluids only) (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    673
    672
    Units: subjects
        Yes
    234
    284
        No
    439
    388
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.94
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -7.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.7
         upper limit
    -2.3

    Secondary: return to oral diet (diet and fluids) (24 hours)

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    End point title
    return to oral diet (diet and fluids) (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    673
    672
    Units: subjects
        Yes
    419
    357
        No
    254
    315
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.07
         upper limit
    1.29
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    9.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.9
         upper limit
    14.4

    Secondary: post-operative anti-emetics given (24 hours)

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    End point title
    post-operative anti-emetics given (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    674
    676
    Units: subjects
        Yes
    265
    351
        No
    409
    325
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.67
         upper limit
    0.85
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -12.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.9
         upper limit
    -7.3

    Secondary: number of types of post-operative anti-emetic given (24 hours)

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    End point title
    number of types of post-operative anti-emetic given (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    672
    673
    Units: subjects
        arithmetic mean (standard deviation)
    0.54 ± 0.76
    0.78 ± 0.88
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1345
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.32
         upper limit
    -0.14

    Secondary: number of doses of post-operative anti-emetics given (24 hours)

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    End point title
    number of doses of post-operative anti-emetics given (24 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    670
    671
    Units: subjects
        arithmetic mean (standard deviation)
    0.77 ± 1.25
    1.07 ± 1.41
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1341
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.45
         upper limit
    -0.17

    Secondary: patient reported clinically important PONV (72 hours)

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    End point title
    patient reported clinically important PONV (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    574
    592
    Units: subjects
        Yes
    96
    93
        No
    478
    499
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1166
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.64
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    1.38
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1166
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.64
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    5.2

    Secondary: patient reported vomiting/retching (72 hours)

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    End point title
    patient reported vomiting/retching (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    612
    616
    Units: subjects
        Yes
    194
    209
        No
    418
    407
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1228
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.41
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    1.1
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1228
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.41
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -2.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.5
         upper limit
    3

    Secondary: patient reported nausea (72 hours)

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    End point title
    patient reported nausea (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    613
    616
    Units: subjects
        Yes
    324
    349
        No
    289
    267
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.84
         upper limit
    1.03
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -3.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.4
         upper limit
    1.8

    Secondary: patient reported nausea - VAS scale (72 hours)

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    End point title
    patient reported nausea - VAS scale (72 hours)
    End point description
    higher scores indicate higher levels of nausea
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    298
    324
    Units: subjects
        arithmetic mean (standard deviation)
    43.8 ± 29.1
    44.5 ± 28.4
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    622
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.2
         upper limit
    3.9

    Secondary: return to any oral diet (72 hours)

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    End point title
    return to any oral diet (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    658
    672
    Units: subjects
        Yes
    649
    664
        No
    9
    8
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1330
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.99
         upper limit
    1.01
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1330
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    1

    Secondary: return to oral diet (fluids only) (72 hours)

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    End point title
    return to oral diet (fluids only) (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    658
    672
    Units: subjects
        Yes
    120
    128
        No
    538
    544
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1330
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.2
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1330
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5
         upper limit
    3.4

    Secondary: return to oral diet (diet and fluids) (72 hours)

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    End point title
    return to oral diet (diet and fluids) (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    658
    672
    Units: subjects
        Yes
    527
    532
        No
    131
    140
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1330
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.68
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.96
         upper limit
    1.07
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1330
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.68
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.4
         upper limit
    5.3

    Secondary: post-operative anti-emetics given (72 hours)

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    End point title
    post-operative anti-emetics given (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    674
    676
    Units: subjects
        Yes
    353
    425
        No
    321
    251
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    0.91
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -10.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.7
         upper limit
    -5.3

    Secondary: number of types of post-operative anti-emetic given (72 hours)

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    End point title
    number of types of post-operative anti-emetic given (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    656
    669
    Units: subjects
        arithmetic mean (standard deviation)
    0.8 ± 0.86
    0.96 ± 0.89
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1325
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.25
         upper limit
    -0.06

    Secondary: number of doses of post-operative anti-emetic given (72 hours)

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    End point title
    number of doses of post-operative anti-emetic given (72 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    25-72 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    653
    665
    Units: subjects
        arithmetic mean (standard deviation)
    1.7 ± 2.45
    2.06 ± 2.61
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1318
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.64
         upper limit
    -0.09

    Secondary: patient reported clinically important PONV (120 hours)

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    End point title
    patient reported clinically important PONV (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    467
    455
    Units: subjects
        Yes
    74
    72
        No
    393
    383
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    922
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.99
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    1.35
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    922
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.99
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.7
         upper limit
    4.7

    Secondary: patient reported vomiting/retching (120 hours)

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    End point title
    patient reported vomiting/retching (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    497
    479
    Units: subjects
        Yes
    132
    129
        No
    365
    350
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    976
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    1.21
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    976
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.9
         upper limit
    5.2

    Secondary: patient reported nausea (120 hours)

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    End point title
    patient reported nausea (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    495
    474
    Units: subjects
        Yes
    224
    205
        No
    271
    269
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    969
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.53
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.91
         upper limit
    1.21
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    969
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.53
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    8.3

    Secondary: patient reported nausea - VAS scale (!20 hours)

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    End point title
    patient reported nausea - VAS scale (!20 hours)
    End point description
    higher scores indicate higher levels of nausea
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    58
    48
    Units: subjects
        arithmetic mean (standard deviation)
    41.9 ± 26.3
    46.5 ± 32.5
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.42
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16
         upper limit
    6.7

    Secondary: return to any oral diet (120 hours)

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    End point title
    return to any oral diet (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    555
    560
    Units: subjects
        Yes
    539
    547
        No
    16
    13
    Statistical analysis title
    Risk Ratio
    Comparison groups
    no Dexamethasone v Dexamethasone
    Number of subjects included in analysis
    1115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.56
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.98
         upper limit
    1.01
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.56
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.4
         upper limit
    1.3

    Secondary: return to oral diet (fluids only) (120 hours)

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    End point title
    return to oral diet (fluids only) (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    555
    560
    Units: subjects
        Yes
    75
    79
        No
    480
    481
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    1.28
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.6
         upper limit
    3.5

    Secondary: return to oral diet (diet and fluids) (120 hours)

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    End point title
    return to oral diet (diet and fluids) (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    555
    560
    Units: subjects
        Yes
    463
    465
        No
    92
    95
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.86
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    1.06
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.86
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    4.8

    Secondary: post-operative anti-emetics given (120 hours)

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    End point title
    post-operative anti-emetics given (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    674
    676
    Units: subjects
        Yes
    276
    285
        No
    398
    391
    Statistical analysis title
    Risk Ratio
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.65
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.86
         upper limit
    1.1
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1350
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.65
    Method
    Chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.5
         upper limit
    4.1

    Secondary: number of types of post-operative anti-emetics given (120 hours)

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    End point title
    number of types of post-operative anti-emetics given (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    553
    557
    Units: subjects
        arithmetic mean (standard deviation)
    0.78 ± 0.90
    0.81 ± 0.94
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1110
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.58
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.14
         upper limit
    0.08

    Secondary: number of doses of post-operative anti-emetics given (120 hours)

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    End point title
    number of doses of post-operative anti-emetics given (120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    73-120 hours post-randomisation
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    553
    555
    Units: subjects
        arithmetic mean (standard deviation)
    2.23 ± 3.70
    2.30 ± 4.10
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1108
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.78
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.53
         upper limit
    0.39

    Secondary: EQ-5D health status score (baseline)

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    End point title
    EQ-5D health status score (baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    636
    637
    Units: subjects
        arithmetic mean (standard deviation)
    0.85 ± 0.19
    0.83 ± 0.21
    Statistical analysis title
    Risk Difference
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1273
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.03
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0.05

    Secondary: EQ-5D health status score (discharge or 120 hours)

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    End point title
    EQ-5D health status score (discharge or 120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    discharge or 120 hours
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    568
    561
    Units: subjects
        arithmetic mean (standard deviation)
    0.54 ± 0.31
    0.52 ± 0.31
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1129
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.41
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.02
         upper limit
    0.05

    Secondary: EQ-5D health status score (30 days)

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    End point title
    EQ-5D health status score (30 days)
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    562
    575
    Units: subjects
        arithmetic mean (standard deviation)
    0.74 ± 0.26
    0.75 ± 0.24
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1137
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.69
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0.02

    Secondary: EQ-5D VAS score (baseline)

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    End point title
    EQ-5D VAS score (baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    642
    640
    Units: subjects
        arithmetic mean (standard deviation)
    75.7 ± 17.8
    74.7 ± 18.3
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.29
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.9
         upper limit
    3

    Secondary: EQ-5D VAS score (discharge or 120 hours)

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    End point title
    EQ-5D VAS score (discharge or 120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    discharge or 120 hours
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    583
    571
    Units: subjects
        arithmetic mean (standard deviation)
    59.2 ± 22.7
    59.6 ± 21.5
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1154
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.74
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    2.1

    Secondary: EQ-5D VAS score (30 days)

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    End point title
    EQ-5D VAS score (30 days)
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    565
    580
    Units: subjects
        arithmetic mean (standard deviation)
    72.4 ± 18.7
    72.4 ± 18.1
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1145
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.98
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    2.1

    Secondary: FACIT-F total score (baseline)

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    End point title
    FACIT-F total score (baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    588
    598
    Units: subjects
        arithmetic mean (standard deviation)
    129.2 ± 22.0
    127.5 ± 23.9
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.9
         upper limit
    4.3

    Secondary: FACIT-F total score (discharge or 120 hours)

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    End point title
    FACIT-F total score (discharge or 120 hours)
    End point description
    End point type
    Secondary
    End point timeframe
    discharge or 120 hours
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    523
    525
    Units: subjects
        arithmetic mean (standard deviation)
    103.0 ± 27.9
    102.0 ± 27.5
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.54
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    4.4

    Secondary: FACIT-F total score (30 days)

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    End point title
    FACIT-F total score (30 days)
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    527
    527
    Units: subjects
        arithmetic mean (standard deviation)
    121.4 ± 25.2
    120.4 ± 26.4
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1054
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    4.2

    Secondary: EQ-5D health status score - change from baseline to discharge/120 hours

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    End point title
    EQ-5D health status score - change from baseline to discharge/120 hours
    End point description
    End point type
    Secondary
    End point timeframe
    change from baseline to discharge/120 hours
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    543
    535
    Units: subjects
        arithmetic mean (standard deviation)
    -0.32 ± 0.33
    -0.31 ± 0.31
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.88
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.04
         upper limit
    0.04

    Secondary: EQ-5D health status score - change from baseline to 30 days

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    End point title
    EQ-5D health status score - change from baseline to 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    change from baseline to 30 days
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    534
    548
    Units: subjects
        arithmetic mean (standard deviation)
    -0.11 ± 0.27
    -0.09 ± 0.26
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1082
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.05
         upper limit
    0.01

    Secondary: EQ-5D VAS score - change from baseline to discharge/120 hours

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    End point title
    EQ-5D VAS score - change from baseline to discharge/120 hours
    End point description
    End point type
    Secondary
    End point timeframe
    change from baseline to discharge/120 hours
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    562
    549
    Units: subjects
        arithmetic mean (standard deviation)
    -16.04 ± 24.55
    -15.25 ± 23.44
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1111
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.58
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    2

    Secondary: EQ-5D VAS score - change from baseline to 30 days

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    End point title
    EQ-5D VAS score - change from baseline to 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    change from baseline to 30 days
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    541
    556
    Units: subjects
        arithmetic mean (standard deviation)
    -3.59 ± 20.99
    -2.46 ± 21.57
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    1097
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.38
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.7
         upper limit
    1.4

    Secondary: FACIT-F total score - change from baseline to discharge/120 hours

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    End point title
    FACIT-F total score - change from baseline to discharge/120 hours
    End point description
    End point type
    Secondary
    End point timeframe
    change from baseline to discharge/120 hours
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    477
    484
    Units: subjects
        arithmetic mean (standard deviation)
    -26.11 ± 28.47
    -26.05 ± 28.23
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    961
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.97
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    3.5

    Secondary: FACIT-F total score - change from baseline to 30 days

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    End point title
    FACIT-F total score - change from baseline to 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    change from baseline to 30 days
    End point values
    Dexamethasone no Dexamethasone
    Number of subjects analysed
    475
    481
    Units: subjects
        arithmetic mean (standard deviation)
    -8.51 ± 26.46
    -7.20 ± 25.53
    Statistical analysis title
    difference in means
    Comparison groups
    Dexamethasone v no Dexamethasone
    Number of subjects included in analysis
    956
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.43
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.6
         upper limit
    2

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The SAEs were collected for all patients in the study from the first trial treatment to 30 days after the last trial treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the intervention treatment arm was: 8 mg IV dexamethasone (plus one other anti-emetic of the anaesthetist’s choice) following induction of anaesthesia but prior to commencement of surgery.

    Reporting group title
    no Dexamethasone
    Reporting group description
    Patients who underwent laparoscopic or open gastrointestinal resections for malignant or benign pathology were randomised, in a 1:1 ratio, between 8mg IV dexamethasone and control. All patients were to be given one additional anti-emetic at the time of induction, however, this must have not been dexamethasone. Thus, the control arm was induction of anti-emetic of the anaesthetist’s choice (not dexamethasone) prior to commencement of surgery.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events were not collected within this trial.
    Serious adverse events
    Dexamethasone no Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    162 / 669 (24.22%)
    155 / 666 (23.27%)
         number of deaths (all causes)
    7
    7
         number of deaths resulting from adverse events
    Vascular disorders
    Hematoma
         subjects affected / exposed
    2 / 669 (0.30%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhage
         subjects affected / exposed
    7 / 669 (1.05%)
    8 / 666 (1.20%)
         occurrences causally related to treatment / all
    1 / 7
    2 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hypotension
         subjects affected / exposed
    2 / 669 (0.30%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic haematoma
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Ascites
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed wound healing
         subjects affected / exposed
    2 / 669 (0.30%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central Line infection
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epidural leak
         subjects affected / exposed
    1 / 669 (0.15%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi organ failure
         subjects affected / exposed
    1 / 669 (0.15%)
    2 / 666 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Peristomal fistula with leak
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Paranoia
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Perineal pain
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic leak
         subjects affected / exposed
    14 / 669 (2.09%)
    25 / 666 (3.75%)
         occurrences causally related to treatment / all
    7 / 14
    13 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Bowel Perforation
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Catheter pain
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall and facial trauma
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    2 / 669 (0.30%)
    4 / 666 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Other - Collection at rectal stump
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Other - Spleen laceration during surgery
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic collections
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Injury
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    13 / 669 (1.94%)
    10 / 666 (1.50%)
         occurrences causally related to treatment / all
    8 / 13
    7 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Derranged Bloods
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Low sodium
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 669 (0.15%)
    2 / 666 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 669 (0.30%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular systolic dysfunction
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 669 (0.30%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shortness of Breath
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    3 / 669 (0.45%)
    3 / 666 (0.45%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 669 (0.15%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 669 (0.30%)
    2 / 666 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 669 (0.30%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Collection
         subjects affected / exposed
    0 / 669 (0.00%)
    2 / 666 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    5 / 669 (0.75%)
    14 / 666 (2.10%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adhesions causing small bowel obstruction
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adhesions to small bowel
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Pain
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel Obstruction
         subjects affected / exposed
    12 / 669 (1.79%)
    6 / 666 (0.90%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bruising of Stoma
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 669 (0.00%)
    4 / 666 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 669 (0.45%)
    3 / 666 (0.45%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Distended Abdomen
         subjects affected / exposed
    0 / 669 (0.00%)
    2 / 666 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    High Stoma Output
         subjects affected / exposed
    6 / 669 (0.90%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    13 / 669 (1.94%)
    18 / 666 (2.70%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Jejunal perforation
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 669 (0.75%)
    3 / 666 (0.45%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal discharge
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulceration with haemorrhage
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal stump dehiscence
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small bowel obstruction
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma complication
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 669 (0.60%)
    7 / 666 (1.05%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acalculous Cholecystitis
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 669 (0.30%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Other - Rectovaginal fistula
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical emphysema
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperparathyroidism
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Infection
         subjects affected / exposed
    2 / 669 (0.30%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    3 / 669 (0.45%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Catheter Infection
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 669 (0.15%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    8 / 669 (1.20%)
    19 / 666 (2.85%)
         occurrences causally related to treatment / all
    3 / 8
    5 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 669 (0.45%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 669 (0.15%)
    2 / 666 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site infection
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    10 / 669 (1.49%)
    8 / 666 (1.20%)
         occurrences causally related to treatment / all
    6 / 10
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal infection
         subjects affected / exposed
    1 / 669 (0.15%)
    0 / 666 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    48 / 669 (7.17%)
    47 / 666 (7.06%)
         occurrences causally related to treatment / all
    37 / 48
    32 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 669 (0.00%)
    1 / 666 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Dexamethasone no Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 669 (0.00%)
    0 / 666 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2011
    Protocol version 2.0 28/APR/2011. Substantial changes: Pilot study added to trial design.
    26 Nov 2013
    Protocol version 3.0 24/Oct/2013. Substantial changes: Clarification of sample size from 950 to 1320 patients; Clarification of primary outcome to 'the proportion of patients experiencing vomiting within 24 hours post-surgery'; Addition of secondary outcome 'number of episodes of vomiting post-surgery'.
    30 Jan 2015
    Protocol version 4.0 20/Jan/2015. Substantial changes: Definition of end of trial to be no later than 1 year after the last visit of the last patient undergoing the trial.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28420629
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