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    Clinical Trial Results:
    Intraoperative methadone in same-day hysterectomy: a prospective, double-blind, randomised controlled trial

    Summary
    EudraCT number
    		 2018-004351-20
    Trial protocol
    		 DK  
    Global end of trial date
    06 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Oct 2023
    First version publication date
    01 Oct 2023
    Other versions
    Summary report(s)
    		 BMJ atricle

    Trial information

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    Trial identification
    Sponsor protocol code
    01122018v2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03908060
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Lone Nikolajsen, Aarhus University Hospital, 0045 78464317, lone.nikolajsen@clin.au.dk
    Scientific contact
    Lone Nikolajsen, Aarhus University Hospital, 0045 78464317, lone.nikolajsen@clin.au.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
    01 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to investigate the effect of a single dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. A single dose of intravenous intraoperative morphine will be used as an active comparator.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and Guidelines for Good Clinical Practice (GCP) and monitored by the GCP unit at Aarhus University Hospital, Aarhus, Denmark. The study protocol was approved by the Danish Protection Agency (ID 1-16-02-747-18), the Central Denmark Region Committees on Health Research Ethics (ID 1-10-72-365-18), and the Danish Health and Medicines Authority (ID 2018-004351-20).
    Background therapy
    		 Laparoscopic hysterectomy is often carried out as day-stay surgery. Minimising postoperative pain is therefore of utmost importance to ensure timely discharge from hospital. Methadone has several desirable pharmacological features, including a long elimination half-life. Therefore, a single intraoperative dose could provide long-lasting pain relief.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Apr 2019
    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: 163
    Worldwide total number of subjects
    163
    EEA total number of subjects
    163
    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)
    152
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were screened for inclusion at the first ambulatory contact at Horsens Regional Hospital, Horsens, Denmark, and informed oral and written consent was obtained before surgery. Adult females scheduled for day-stay, elective, laparoscopic hysterectomy were enrolled.

    Pre-assignment
    Screening details
    		 Patients were screened for inclusion at the first ambulatory contact at Horsens Regional Hospital, Horsens, Denmark, and informed oral and written consent was obtained before surgery. Adult females scheduled for day-stay, elective, laparoscopic hysterectomy were enrolled.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 A 10 mL syringe with 2 mg/mL of methadone was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methadone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    A 10 mL syringe with 2 mg/mL of methadone was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.

    Arm title
    		 Control
    Arm description
    		 A 10 mL syringe with 2 mg/mL of morphine was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Morphine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    A 10 mL syringe with 2 mg/mL of morphine was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.

    Number of subjects in period 1
    		Intervention Control
    Started
    81
    82
    Completed
    64
    63
    Not completed
    17
    19
         Consent withdrawn by subject
    4
    2
         Inoperable
    1
    2
         Converted to open surgery
    2
    3
         Did not receive study drug from hospital pharmacy
    6
    8
         Surgery postponed to after study completion
    1
    -
         Prolonged QT interval
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 A 10 mL syringe with 2 mg/mL of methadone was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.

    Reporting group title
    Control
    Reporting group description
    		 A 10 mL syringe with 2 mg/mL of morphine was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 81 82 163
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 76 76 152
        From 65-84 years
    		 5 6 11
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 81 82 163
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 A 10 mL syringe with 2 mg/mL of methadone was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.

    Reporting group title
    Control
    Reporting group description
    		 A 10 mL syringe with 2 mg/mL of morphine was prepared. The dose of the study drug was be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg) corresponding to 1 mL for every 10 kg of ideal body weight (height [cm]—105), rounded to the nearest half.

    Primary: Opioid consumption 0‐24 hours

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    End point title
    		 Opioid consumption 0‐24 hours
    End point description
    End point type
    Primary
    End point timeframe
    Opioid consumption 0‐24 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: mg
        median (inter-quartile range (Q1-Q3))
    42 (10 to 67)
    54.5 (31 to 83)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Opioid consumption 0‐6 hours

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    End point title
    		 Opioid consumption 0‐6 hours
    End point description
    End point type
    Primary
    End point timeframe
    Opioid consumption 0‐6 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: mg
        median (inter-quartile range (Q1-Q3))
    35.5 (0 to 61)
    48 (31 to 74.5)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain intensity (NRS, 0‐10) at rest at 1 hour

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest at 1 hour
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    3 (2 to 5)
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at rest at 6 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 6 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest at 6 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    2 (1 to 3)
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at rest at 24 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest at24 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 5)
    2 (1 to 4)
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at rest at 48 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 48 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest and at 48 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    3 (1 to 3)
    No statistical analyses for this end point

    Secondary: Patient satisfaction (NRS, 0‐10) with pain management at 3 hours

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    End point title
    		 Patient satisfaction (NRS, 0‐10) with pain management at 3 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Patient satisfaction (NRS, 0‐10) with pain management at 3 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    10 (9 to 10)
    10 (9 to 10)
    No statistical analyses for this end point

    Secondary: Patient satisfaction (NRS, 0‐10) with pain management at 24 hours

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    End point title
    		 Patient satisfaction (NRS, 0‐10) with pain management at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Patient satisfaction (NRS, 0‐10) with pain management at 24 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    9 (7 to 10)
    9 (8 to 10)
    No statistical analyses for this end point

    Secondary: PONV (none/mild/moderate/severe) at 6 hours

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    End point title
    		 PONV (none/mild/moderate/severe) at 6 hours
    End point description
    End point type
    Secondary
    End point timeframe
    PONV (none/mild/moderate/severe) at 6 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
        None or mild
    49
    42
        Moderate or severe
    15
    20
    No statistical analyses for this end point

    Secondary: PONV (none/mild/moderate/severe) at 24 hours

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    End point title
    		 PONV (none/mild/moderate/severe) at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    PONV (none/mild/moderate/severe) at 24 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
        None or mild
    49
    51
        Moderate or severe
    15
    12
    No statistical analyses for this end point

    Secondary: PONV (none/mild/moderate/severe) at 72 hours

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    End point title
    		 PONV (none/mild/moderate/severe) at 72 hours
    End point description
    End point type
    Secondary
    End point timeframe
    PONV (none/mild/moderate/severe) at 72 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
        None or mild
    56
    59
        Moderate or severe
    7
    4
    No statistical analyses for this end point

    Secondary: Ramsey Sedation Scale, Level 2, 0.5 hours

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    End point title
    		 Ramsey Sedation Scale, Level 2, 0.5 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Ramsey Sedation Scale, Level 2, 0.5 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    50
    47
    No statistical analyses for this end point

    Secondary: Ramsey Sedation Scale, Level 2, 1 hour

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    End point title
    		 Ramsey Sedation Scale, Level 2, 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    Ramsey Sedation Scale, Level 2, 1 hour
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    44
    45
    No statistical analyses for this end point

    Secondary: Ramsey Sedation Scale, Level 2, 3 hours

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    End point title
    		 Ramsey Sedation Scale, Level 2, 3 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Ramsey Sedation Scale, Level 2, 3 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    52
    57
    No statistical analyses for this end point

    Secondary: Ventilatory frequency <10 min in PACU

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    End point title
    		 Ventilatory frequency <10 min in PACU
    End point description
    End point type
    Secondary
    End point timeframe
    In PACU
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    1
    1
    No statistical analyses for this end point

    Secondary: Oxygen saturation <94% in PACU

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    End point title
    		 Oxygen saturation <94% in PACU
    End point description
    End point type
    Secondary
    End point timeframe
    In PACU
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    0
    1
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at coughing at 1 hour

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 1 hour
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 1 hour
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 5)
    4 (3 to 6)
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at coughing at 6 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 6 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 6 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 5)
    3 (2 to 5)
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at coughing at 24 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 24 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    5 (3 to 7)
    5 (3 to 7)
    No statistical analyses for this end point

    Secondary: Pain intensity (NRS, 0‐10) at coughing at 48 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 48 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 48 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    4 (3 to 6)
    5 (3 to 7)
    No statistical analyses for this end point

    Other pre-specified: Pain intensity (NRS, 0‐10) at rest at 0.5 hour

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 0.5 hour
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest at 0.5 hour
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 5)
    5 (3 to 6)
    No statistical analyses for this end point

    Other pre-specified: Pain intensity (NRS, 0‐10) at coughing at 0.5 hour

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 0.5 hour
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 0.5 hour
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3.5 (3 to 6)
    5 (4 to 7)
    No statistical analyses for this end point

    Other pre-specified: Pain intensity (NRS, 0‐10) at rest at 3 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 3 hours
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest at 3 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    2 (1 to 3)
    No statistical analyses for this end point

    Other pre-specified: Pain intensity (NRS, 0‐10) at coughing at 3 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 3 hours
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 3 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    3 (2 to 4)
    No statistical analyses for this end point

    Other pre-specified: Pain intensity (NRS, 0‐10) at rest at 72 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at rest at 72 hours
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Pain intensity (NRS, 0‐10) at rest and at 72 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    3 (1 to 3)
    1 (0 to 3)
    No statistical analyses for this end point

    Other pre-specified: Pain intensity (NRS, 0‐10) at coughing at 72 hours

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    End point title
    		 Pain intensity (NRS, 0‐10) at coughing at 72 hours
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Pain intensity (NRS, 0‐10) at coughing at 72 hours
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: NRS, 0-10
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    4 (3 to 6)
    No statistical analyses for this end point

    Other pre-specified: ASA physical status

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    End point title
    		 ASA physical status
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Preoperatively
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
        "1"
    29
    26
        "2"
    31
    36
        "3"
    3
    1
        Missing
    1
    0
    No statistical analyses for this end point

    Other pre-specified: Minor laparotomy performed

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    End point title
    		 Minor laparotomy performed
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    11
    11
    No statistical analyses for this end point

    Other pre-specified: Vasopressor (Ephedrine)

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    End point title
    		 Vasopressor (Ephedrine)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
        Vasopressor (Ephedrine)
    53
    48
    No statistical analyses for this end point

    Other pre-specified: BMI

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    End point title
    		 BMI
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Preoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: kg/m2
        arithmetic mean (confidence interval 95%)
    26.9 (25.7 to 28.0)
    27.1 (26.3 to 28.7)
    No statistical analyses for this end point

    Other pre-specified: Bleeding

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    End point title
    		 Bleeding
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: ml
        median (inter-quartile range (Q1-Q3))
    50 (20 to 100)
    75 (20 to 150)
    No statistical analyses for this end point

    Other pre-specified: Uterus weight

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    End point title
    		 Uterus weight
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Interaoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: mg
        median (inter-quartile range (Q1-Q3))
    216 (130 to 428)
    204 (100 to 401)
    No statistical analyses for this end point

    Other pre-specified: Crystalloids

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    End point title
    		 Crystalloids
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperativ
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: ml
        median (inter-quartile range (Q1-Q3))
    1200 (1037 to 1400)
    1250 (1100 to 1400)
    No statistical analyses for this end point

    Other pre-specified: Propofol

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    End point title
    		 Propofol
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: ml
        arithmetic mean (confidence interval 95%)
    103.8 (95.5 to 112.1)
    110.9 (102.5 to 119.4)
    No statistical analyses for this end point

    Other pre-specified: Remifentanil

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    End point title
    		 Remifentanil
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: ml
        arithmetic mean (confidence interval 95%)
    87.2 (78.7 to 95.7)
    93.7 (85.9 to 101.5)
    No statistical analyses for this end point

    Other pre-specified: Anaesthesia duration

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    End point title
    		 Anaesthesia duration
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Interaoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: min
        median (inter-quartile range (Q1-Q3))
    160 (144 to 185)
    160 (145 to 190)
    No statistical analyses for this end point

    Other pre-specified: Surgery duration

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    End point title
    		 Surgery duration
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: min
        median (inter-quartile range (Q1-Q3))
    108 (90 to 130)
    107 (91 to 120)
    No statistical analyses for this end point

    Other pre-specified: Time from drug administration to extubation

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    End point title
    		 Time from drug administration to extubation
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Intraoperative
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: min
        median (inter-quartile range (Q1-Q3))
    65 (55 to 75)
    63 (51 to 77)
    No statistical analyses for this end point

    Other pre-specified: Same-day discharge

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    End point title
    		 Same-day discharge
    End point description
    End point type
    Other pre-specified
    End point timeframe
    During hospitalisation
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
        number (not applicable)
    47
    44
    No statistical analyses for this end point

    Other pre-specified: Reason for overnight stay

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    End point title
    		 Reason for overnight stay
    End point description
    End point type
    Other pre-specified
    End point timeframe
    During hospitalisaation
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: n
    number (not applicable)
        Pain
    2
    3
        PONV
    7
    7
        No reason specified
    2
    2
        Other
    6
    7
    No statistical analyses for this end point

    Other pre-specified: Time in hospital

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    End point title
    		 Time in hospital
    End point description
    End point type
    Other pre-specified
    End point timeframe
    During hospitalisation
    End point values
    		 Intervention Control
    Number of subjects analysed
    64
    63
    Units: min
        median (inter-quartile range (Q1-Q3))
    354 (273 to 998)
    394 (318 to 1139)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 64 (34.38%)
    19 / 63 (30.16%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Hospitalisation due to heavy bleeding
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Re-operation after primary surgery due to incomplete closure of the surgical wound
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia during surgery
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (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
    Prolonged hospitalisation due to postoperoperative symprtoms including PONV, dizziness, low blood pr
         subjects affected / exposed
    15 / 64 (23.44%)
    12 / 63 (19.05%)
         occurrences causally related to treatment / all
    15 / 15
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prolonged hospitalisation due to insecurity with discharge
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Hospitalisation due to a bleeding gastric ulcer
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation due to pain caused by lack of flatus and bowel movement (sub-ileus)
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Desaturation
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Prolonged hospitalisation due to lack of urination
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Admitted to hospital in 3 days after surgery due to pain and fever
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reoperation due to wound infection
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intervention Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 64 (18.75%)
    7 / 63 (11.11%)
    General disorders and administration site conditions
    Outpatient check-up due to bleeding
         subjects affected / exposed
    3 / 64 (4.69%)
    2 / 63 (3.17%)
         occurrences all number
    5
    2
    Outpatient check-up due to postoperative symptoms
    Additional description: Outpatient check-up due to postoperative symptoms e.g. questions regarding bandage
         subjects affected / exposed
    4 / 64 (6.25%)
    4 / 63 (6.35%)
         occurrences all number
    7
    4
    Outpatient check-up due to postoperative pain
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 63 (1.59%)
         occurrences all number
    3
    3
    Outpatient check-up of sutur
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Postoperative infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37638073
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