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    Clinical Trial Results:
    Effect of high versus low dose intravenous dexamethason on complications in the immediate postoperative setting after mastectomy - a randomized, double-blind, controlled trial

    Summary
    EudraCT number
    		 2017-000227-27
    Trial protocol
    		 DK  
    Global end of trial date
    29 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2019
    First version publication date
    06 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEXMAS01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03125941
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 31666112, kste0050@regionh.dk
    Scientific contact
    Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 +4531666112, kste0050@regionh.dk
    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
    21 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of high versus low dose intravenous dexamethasone on complications in the immediate postoperative setting after mastectomy. Main objective is proportion of patientes needing admission to postanaesthesia care unit after operation.
    Protection of trial subjects
    Study medication was medication already being used, just in two different doses
    Background therapy
    		 All other therapy followed local standard protocol
    Evidence for comparator
    		 4-8 mg of dexamethasone is a standard prohylactic treatment for post-operative nausea and vomiting. 125 mg methylprednisolone (equivalent to 24 mg of dexamethasone) has been shown to reduce pain in the first days after hip and knee replacements (Lunn TH, 2011, 2013).
    Actual start date of recruitment
    03 Apr 2017
    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
    Denmark: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    51
    From 65 to 84 years
    74
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment by investigator or study personell at the pre-operative consultation, at the department of breast surgery

    Pre-assignment
    Screening details
    		 Screening by doctors from the department of breast surgery and investigator: all adult patients undergoing mastectomy were screened for inclusion

    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, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Personnel not otherwise involved in trial prepared study drug: either 6 ml dexamethasone (24 mg) or 2 ml dexamethasone (8 mg) and 4 ml nacl. Syringes containing both solutions were clear and identical in appearence.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dexamethasone 8 mg
    Arm description
    		 Single-shot preoperative injection
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg (2 ml) with 4 ml nacl, injected single-shot

    Arm title
    		 Dexamethasone 24 mg
    Arm description
    		 Single shot pre-operative injection, 24 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    24 mg (6 ml) injected as a pre-operative single-shot

    Number of subjects in period 1
    		Dexamethasone 8 mg Dexamethasone 24 mg
    Started
    65
    65
    Completed
    63
    64
    Not completed
    2
    1
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 130 patients were randomized, 3 pre-intervention exclusions, so 127 received the intervention. Baseline characteristics reported for all patients, endpoints only for patients receiving intervention

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 130 130
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 81 81
        From 65-84 years
    		 44 44
        85 years and over
    		 5 5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 65 (24 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 128 128
        Male
    		 2 2
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 25 ( 5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Dexamethasone 8 mg
    Reporting group description
    		 Single-shot preoperative injection

    Reporting group title
    Dexamethasone 24 mg
    Reporting group description
    		 Single shot pre-operative injection, 24 mg

    Primary: proportion of patients transferred to PACU

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    End point title
    		 proportion of patients transferred to PACU
    End point description
    Proportion of patients transferred to the post-anesthesia care unit after operation (vs. patients transferred directly to the ward)
    End point type
    Primary
    End point timeframe
    1 hour
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [1]
    64 [2]
    Units: patients
    23
    23
    Notes
    [1] - 1 pre-intervention exclusion
    [2] - 2 pre-intervention exclusion
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    patients meeting criteria for transfer to PACU according to standardized discharge score
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 2.05

    Secondary: Discharge scores

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    End point title
    		 Discharge scores
    End point description
    Standardized discharge score (modified Aldrete criteria), at extubation and transfer from operating room and upon arrival at the ward
    End point type
    Secondary
    End point timeframe
    12 h
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [3]
    64 [4]
    Units: score
    median (inter-quartile range (Q1-Q3))
        extubation
    0 (0 to 2)
    1 (0 to 2)
        transfer from OR
    1 (0 to 2)
    1 (0 to 2)
        arrival at ward
    1 (1 to 2)
    1 (1 to 2)
    Notes
    [3] - 2 pre-intervention exclusion
    [4] - 1 pre-intervention exclusion
    Statistical analysis title
    		 discharge scores
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.114 [5]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - at transfer 0.294, ward 0.076

    Secondary: Pain scores

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    End point title
    		 Pain scores
    End point description
    Pain scores at extubation, transfer from the operating room and arrival at ward
    End point type
    Secondary
    End point timeframe
    12 h
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [6]
    64 [7]
    Units: numeric rating scale
    median (inter-quartile range (Q1-Q3))
        extubation
    0 (0 to 0)
    0 (0 to 0)
        transfer from OR
    0 (0 to 0)
    0 (0 to 0)
        arrival at ward
    2 (1 to 3)
    1 (0 to 3)
    Notes
    [6] - 2 pre-intervention exclusion
    [7] - 1 pre-intervention exclusion
    Statistical analysis title
    		 pain scores
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009 [8]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [8] - at transfer 0.416, arrival at ward 0.097

    Secondary: Lenght of stay

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    End point title
    		 Lenght of stay
    End point description
    lenght of stay, measured from start of operation to discharge from hospital (hospital), or end of operation to discharge from PACU (PACU)
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [9]
    64 [10]
    Units: hours
    median (inter-quartile range (Q1-Q3))
        LOS, Hospital
    9.2 (7.4 to 24.4)
    11 (8.1 to 23.5)
        LOS, PACU
    2 (1.4 to 2.4)
    1.5 (1.4 to 2.1)
    Notes
    [9] - 2 pre-intervention exclusion
    [10] - 1 pre-intervention exclusion
    Statistical analysis title
    		 LOS
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.217 [11]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [11] - PACU 0.350

    Secondary: Readmission

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    End point title
    		 Readmission
    End point description
    any readmission (other than scheduled oncological)
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [12]
    64 [13]
    Units: number of patients
    4
    4
    Notes
    [12] - 2 pre-intervention exclusion
    [13] - 2 pre-intervention exclusion
    Statistical analysis title
    		 readmissions
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.243
         upper limit
    		 4.3

    Secondary: Seroma

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    End point title
    		 Seroma
    End point description
    no of patients with seroma requiring drainage
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [14]
    64 [15]
    Units: number of patients
    51
    60
    Notes
    [14] - 2 pre-intervention exclusion
    [15] - 1 pre-intervention exclusion
    Statistical analysis title
    		 seroma
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 11.6

    Secondary: wound infection

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    End point title
    		 wound infection
    End point description
    no of patients with wound infection req treatment
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [16]
    64 [17]
    Units: no of patients
    1
    3
    Notes
    [16] - 2 pre-intervention exclusion
    [17] - 1 pre-intervention exclusion
    Statistical analysis title
    		 wound infection
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.315
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 3.24

    Post-hoc: Proportion of patients actually transferred

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    End point title
    		 Proportion of patients actually transferred
    End point description
    Post-hoc analysis of patients actually transferred to PACU, since not all patients who met the criteria for transfer were actually transferred
    End point type
    Post-hoc
    End point timeframe
    1 h
    End point values
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Number of subjects analysed
    63 [18]
    64 [19]
    Units: patients
    12
    12
    Notes
    [18] - 2 pre-intervention exclusion
    [19] - 1 pre-intervention exclusion
    Statistical analysis title
    		 post hoc primary endpoint
    Comparison groups
    Dexamethasone 8 mg v Dexamethasone 24 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 2.43

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    60 hours from intervention administration
    Adverse event reporting additional description
    Patient charts, patient questionnaire
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2019-09-30
    Reporting groups
    Reporting group title
    Dexamethasone 8 mg
    Reporting group description
    		 Single-shot preoperative injection

    Reporting group title
    Dexamethasone 24 mg
    Reporting group description
    		 Single shot pre-operative injection, 24 mg

    Serious adverse events
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 63 (7.94%)
    3 / 64 (4.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Haemorrhage
    Additional description: postoperative wound hemorrhage/hematoma
         subjects affected / exposed
    5 / 63 (7.94%)
    3 / 64 (4.69%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dexamethasone 8 mg Dexamethasone 24 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 63 (9.52%)
    8 / 64 (12.50%)
    Surgical and medical procedures
    Haemorrhage
         subjects affected / exposed
    6 / 63 (9.52%)
    3 / 64 (4.69%)
         occurrences all number
    6
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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