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    Clinical Trial Results:
    A psychomotor recuperation study after deep sedation for colonoscopy between target controlled and manual titration of propofol.

    Summary
    EudraCT number
    		 2014-005215-16
    Trial protocol
    		 BE  
    Global end of trial date
    21 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2021
    First version publication date
    29 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUB-MentalRecup001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02314559
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Brugmann
    Sponsor organisation address
    4 Place A. Van Gehuchten, Brussels, Belgium, 1020
    Public contact
    Anesthesiology Service , CHU Brugmann, 32 024773996, Philippe.VANDERLINDEN@chu-brugmann.be
    Scientific contact
    Anesthesiology Service , CHU Brugmann, 32 024773996, Philippe.VANDERLINDEN@chu-brugmann.be
    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 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Our aim is to evaluate efficacy and recovery after manual titration and target controlled infusion (TCI) of propofol, during colonoscopy, for ambulatory patients. We will evaluate both groups during and after colonoscopy for adverse events, quality of sedation and recovery of psychomotor function.
    Protection of trial subjects
    The study followed the standard of care regarding pain mangement.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 154
    Worldwide total number of subjects
    154
    EEA total number of subjects
    154
    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)
    109
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 184 patients were assessed for eligibility. 164 patients were randomized. 10 patients were excluded (withdrew consent, modified procedures, cancelled procedures and technical problems, hospitalizations). 154 patients were analyzed.

    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, Assessor, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bolus group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Propofol 10mg/ml (Diprivan)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10mg/ml, intravenous administration.

    Arm title
    		 TCI Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propofol 10mg/ml (Diprivan)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10mg/ml, intravenous administration.

    Number of subjects in period 1
    		Bolus group TCI Group
    Started
    79
    75
    Completed
    79
    75

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bolus group
    Reporting group description
    		 -

    Reporting group title
    TCI Group
    Reporting group description
    		 -

    Reporting group values
    		 Bolus group TCI Group Total
    Number of subjects
    		 79 75 154
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 53 56 109
        From 65-84 years
    		 26 19 45
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 47 38 85
        Male
    		 32 37 69

    End points

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    End points reporting groups
    Reporting group title
    Bolus group
    Reporting group description
    		 -

    Reporting group title
    TCI Group
    Reporting group description
    		 -

    Primary: Differences in 'fit for discharge' time

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    End point title
    		 Differences in 'fit for discharge' time
    End point description
    End point type
    Primary
    End point timeframe
    up to 60 minutes after colonoscopy cessation
    End point values
    		 Bolus group TCI Group
    Number of subjects analysed
    79
    75
    Units: minutes
    20
    20
    Statistical analysis title
    		 Mann-Whitney UTest
    Comparison groups
    Bolus group v TCI Group
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Clinical Practice
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Bolus group
    Reporting group description
    		 -

    Reporting group title
    TCI Group
    Reporting group description
    		 -

    Serious adverse events
    		 Bolus group TCI Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 75 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bolus group TCI Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 79 (49.37%)
    38 / 75 (50.67%)
    Cardiac disorders
    Hypotension (intraoperative)
    Additional description: Intraoperative hypotension
         subjects affected / exposed
    39 / 79 (49.37%)
    38 / 75 (50.67%)
         occurrences all number
    1
    1
    Hypotension (post-operative)
    Additional description: Post-operative hypotension
         subjects affected / exposed
    17 / 79 (21.52%)
    21 / 75 (28.00%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Upper airway obstruction
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 75 (5.33%)
         occurrences all number
    1
    1
    Oxygen saturation decreased (intraoperative)
    Additional description: Intraoperative desaturation
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1
    Oxygen saturation decreased (postoperative)
    Additional description: Postoperative period
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2016
    Change of principal investigator and increase of trial duration
    29 May 2017
    Increase of trial duration
    24 Apr 2018
    Increase of trial duration
    27 Aug 2018
    Principal investigator change and increase of trial duration

    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
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    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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