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    Clinical Trial Results:
    Patient Satisfacation of Propofol versus Midazolam and Fentanyl Sedation during Colonoscopy in Inflammatory Bowel Disease

    Summary
    EudraCT number
    		 2013-002428-17
    Trial protocol
    		 DK  
    Global end of trial date
    30 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2021
    First version publication date
    17 Mar 2021
    Other versions
    Summary report(s)
    		 Full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    2013052044
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01934088
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Borgmester Ib Juuls vej 1, Herlev, Denmark, 2730
    Public contact
    Jeppe Thue Jensen, Gastroenheden D, Herlev Hospital, 0045 26136032, jeppe.thue.jensen.01@regionh.dk
    Scientific contact
    Jeppe Thue Jensen, Gastroenheden D, Herlev Hospital, 0045 26136032, jeppe.thue.jensen.01@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
    30 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study if patients with inflammatory bowel disease prefer sedation with propofol or midazolam/fentanyl for their colonoscopy, and if the sedation of choice can increase adherence to treatment program
    Protection of trial subjects
    Trial subjects were randomized to one of two possible standard treatments available in our department. The treatments were unmodified.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2013
    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)
    110
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients included were ≥18 years of age and were scheduled for colonoscopy as part of our standard of care for IBD, or as part of diagnostic workup in patients suspected for having IBD. 320 patients were screened. 130 patients were included. Of the 190 patients declining inclusion, 133 opted out due to specific sedation preferences.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propofol sedation
    Arm description
    		 Deep sedation with propofol administered by a designated nurse supervised by the endoscopist.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propofol "B. Braun"
    Investigational medicinal product code
    N01AX10
    Other name
    Pharmaceutical forms
    Emulsion for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Propofol 10 mg/ml Emulsion. Induction with bolus 20-80 mg (100 minus patient age) and subsequent induction bolus corresponding to half the initial dose 10-40 mg. Sedation maintenance with bolus 10-20 mg every 1-2 minute, if the patients shows signs of being awake, or is otherwise respiratory and cirkulatory stable.

    Arm title
    		 Midazolam/fentanyl sedation
    Arm description
    		 Moderate sedation was administered by a dedicated nurse supervised by the endoscopist. Initial Fentanyl dose of 0.05 mg (≤60 years of age) and 0.025 mg (≥61 years of age) was administered at least five minutes prior to procedure. Induction dose with Midazolam was 1-5 mg and 0.5-2 mg for maintenance when necessary.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fentanyl "B. Braun
    Investigational medicinal product code
    N05CD08, N01AH01
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction dose with Midazolam was 1-5 mg and 0.5-2 mg for maintenance when necessary.

    Investigational medicinal product name
    Fentanyl "B. Braun
    Investigational medicinal product code
    N01AH01
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intraventricular use
    Dosage and administration details
    Sedation was administered by a dedicated nurse supervised by the endoscopist according to local protocol.12 Initial Fentanyl dose of 0.05 mg (≤60 years of age) and 0.025 mg (≥61 years of age) was administered at least five minutes prior to procedure.

    Number of subjects in period 1
    		Propofol sedation Midazolam/fentanyl sedation
    Started
    63
    67
    Completed
    62
    64
    Not completed
    1
    3
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Propofol sedation
    Reporting group description
    		 Deep sedation with propofol administered by a designated nurse supervised by the endoscopist.

    Reporting group title
    Midazolam/fentanyl sedation
    Reporting group description
    		 Moderate sedation was administered by a dedicated nurse supervised by the endoscopist. Initial Fentanyl dose of 0.05 mg (≤60 years of age) and 0.025 mg (≥61 years of age) was administered at least five minutes prior to procedure. Induction dose with Midazolam was 1-5 mg and 0.5-2 mg for maintenance when necessary.

    Reporting group values
    		 Propofol sedation Midazolam/fentanyl sedation Total
    Number of subjects
    		 63 67 130
    Age categorical
    Units: Subjects
        Age = or > 18 years
    		 63 67 130
    Gender categorical
    Units: Subjects
        Female
    		 26 38 64
        Male
    		 37 29 66
    Subject analysis sets

    Subject analysis set title
    Propofol sedation
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    63 patients. Age at study, mean years (SD) 41.9 (13.3). ASA class, mean (SD) 1.38 (0.49); BMI, mean kg/m2 (SD) 24.8 (4.0); Sedative drug mg, mean (SD) 342 (139);Sedation time minutes, mean (SD) 29.9 (11.5); Sleep score 1-5 during intervention, mean (SD)1=awake, 5=asleep: 4.71 (0.72) Indication for colonoscopy, no. (%) Diagnostic 19 (30); Evaluation of disease activity at suspected flare 25 (40); Evaluation of disease activity during remission 9 (14); Surveillance for cancer 10 (16).

    Subject analysis set title
    Midazolam/fentanyl sedation
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    67 patients. Age at study, mean years (SD) 41.2 (14.0); ASA class, mean (SD) 1.38 (0.49); BMI, mean kg/m2 (SD) 24.4 (3.7); Sedative drug mg (Midazolam/Fentanyl), mean (SD)2.4 (0.5) / 0.06 (0.02); Sedation time minutes, mean (SD) 29.1 (13.6); Sleep score 1-5 during intervention, mean (SD) 1=awake, 5=asleep: 1.31 (0.74). Indication for colonoscopy, no. (%): Diagnostic 18 (27); Evaluation of disease activity at suspected flare 24 (36); Evaluation of disease activity during remission 18 (27); Surveillance for cancer 7 (10)

    Subject analysis sets values
    		 Propofol sedation Midazolam/fentanyl sedation
    Number of subjects
    63
    67
    Age categorical
    Units: Subjects
        Age = or > 18 years
    63
    67
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    26
    38
        Male
    37
    29

    End points

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    End points reporting groups
    Reporting group title
    Propofol sedation
    Reporting group description
    		 Deep sedation with propofol administered by a designated nurse supervised by the endoscopist.

    Reporting group title
    Midazolam/fentanyl sedation
    Reporting group description
    		 Moderate sedation was administered by a dedicated nurse supervised by the endoscopist. Initial Fentanyl dose of 0.05 mg (≤60 years of age) and 0.025 mg (≥61 years of age) was administered at least five minutes prior to procedure. Induction dose with Midazolam was 1-5 mg and 0.5-2 mg for maintenance when necessary.

    Subject analysis set title
    Propofol sedation
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    63 patients. Age at study, mean years (SD) 41.9 (13.3). ASA class, mean (SD) 1.38 (0.49); BMI, mean kg/m2 (SD) 24.8 (4.0); Sedative drug mg, mean (SD) 342 (139);Sedation time minutes, mean (SD) 29.9 (11.5); Sleep score 1-5 during intervention, mean (SD)1=awake, 5=asleep: 4.71 (0.72) Indication for colonoscopy, no. (%) Diagnostic 19 (30); Evaluation of disease activity at suspected flare 25 (40); Evaluation of disease activity during remission 9 (14); Surveillance for cancer 10 (16).

    Subject analysis set title
    Midazolam/fentanyl sedation
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    67 patients. Age at study, mean years (SD) 41.2 (14.0); ASA class, mean (SD) 1.38 (0.49); BMI, mean kg/m2 (SD) 24.4 (3.7); Sedative drug mg (Midazolam/Fentanyl), mean (SD)2.4 (0.5) / 0.06 (0.02); Sedation time minutes, mean (SD) 29.1 (13.6); Sleep score 1-5 during intervention, mean (SD) 1=awake, 5=asleep: 1.31 (0.74). Indication for colonoscopy, no. (%): Diagnostic 18 (27); Evaluation of disease activity at suspected flare 24 (36); Evaluation of disease activity during remission 18 (27); Surveillance for cancer 7 (10)

    Primary: Patient satisfaction with sedation

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    End point title
    		 Patient satisfaction with sedation
    End point description
    The satisfaction questionnaire consists 13 items. Each item can be scored from 1-5, with 5 representing a better experience with the sedation.
    End point type
    Primary
    End point timeframe
    Satisfaction questionnaire is completed before discharge from the recovery area.
    End point values
    		 Propofol sedation Midazolam/fentanyl sedation Propofol sedation Midazolam/fentanyl sedation
    Number of subjects analysed
    62
    64
    62
    64
    Units: 13-65
        number (not applicable)
    62
    64
    62
    64
    Attachments
    		 Table 1
    Statistical analysis title
    		 One-Way Analysis of Variance
    Statistical analysis description
    Comparison of satisfaction scores
    Comparison groups
    Midazolam/fentanyl sedation v Propofol sedation
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the procedure and within 1 hour of discharge
    Adverse event reporting additional description
    Apnea with bag valve ventilation: 1 patient. Hypoxia (< 92% saturation): 6 patients. Hypotension: 7 patients
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Propofol sedation
    Reporting group description
    		 Deep sedation with propofol administered by a designated nurse supervised by the endoscopist.

    Reporting group title
    Midazolam/fentanyl sedation
    Reporting group description
    		 Moderate sedation was administered by a dedicated nurse supervised by the endoscopist. Initial Fentanyl dose of 0.05 mg (≤60 years of age) and 0.025 mg (≥61 years of age) was administered at least five minutes prior to procedure. Induction dose with Midazolam was 1-5 mg and 0.5-2 mg for maintenance when necessary.

    Serious adverse events
    		 Propofol sedation Midazolam/fentanyl sedation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Apnoea
    Additional description: Midazolam and fentanyl induced apnoea with hypoxia (85% SAT) needing short ventilation with facemask.
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         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
    		 Propofol sedation Midazolam/fentanyl sedation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 63 (6.35%)
    8 / 67 (11.94%)
    Cardiac disorders
    Hypotension
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 67 (4.48%)
         occurrences all number
    4
    3
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 63 (0.00%)
    6 / 67 (8.96%)
         occurrences all number
    0
    6
    Apnoea
    Additional description: apnoea needing face mask ventilation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences all number
    0
    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.
    Small sample size. Large proportion of screened patients excluded due to specific sedation preferences. Lack of a properly validated satisfaction questionnaire.
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