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    Clinical Trial Results:
    Doxapram as an Additive to Propofol Sedation in Sedation for ERCP - a Placebo controlled, randomized, double-blinded, prospective study

    Summary
    EudraCT number
    		 2013-003873-85
    Trial protocol
    		 FI  
    Global end of trial date
    01 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2022
    First version publication date
    20 May 2022
    Other versions
    Summary report(s)
    		 doxapram as an additive to ERCP

    Trial information

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    Trial identification
    Sponsor protocol code
    PCS02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02171910
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinki University Hospital
    Sponsor organisation address
    Haartmaninkatu 3, Helsinki, Finland, 00290
    Public contact
    Endoscopy unit / HUCH, Helsinki University central Hospital, jarno.jokelainen@gmail.com
    Scientific contact
    Endoscopy unit / HUCH, Helsinki University central Hospital, jarno.jokelainen@gmail.com
    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
    23 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    this study was carried out to assess the efficacy of doxapram as an additive to deep propofol sedation in reducing the incidence of respiratory depression in a randomized double-blinded protocol
    Protection of trial subjects
    Normal clinical precautions and sedation during the procedure
    Background therapy
    		 -
    Evidence for comparator
    		 placebo
    Actual start date of recruitment
    01 Nov 2016
    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
    Finland: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    27
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 56 patients scheduled for an ERCP procedure from November to December 2016 in Helsinki university hospital were enrolled in the study

    Pre-assignment
    Screening details
    		 Exclusion criteria were age > 75, epilepsy, coronary artery disease (stable or unstable angina pectoris), chronic obstructive pulmonary disease, acute alcohol withdrawal syndrome, allergy to propofol, or doxapram.

    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
    The patient and the anesthesiologist who was also responsible for the data collection were blinded to the study drug administered as well as data analyst.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Doxapram
    Arm description
    		 Group receiving doxapram
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doxapram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    the patients received an initial bolus of doxapram 10 mg/ml 0.1 ml/kg and an infusion of doxapram 10 mg/ml at 0.1 ml/kg/h

    Arm title
    		 Placebo
    Arm description
    		 Group receiving placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride 0,9%
    Investigational medicinal product code
    Other name
    normal saline
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo dosing as in the doxapram group

    Number of subjects in period 1
    		Doxapram Placebo
    Started
    28
    28
    Completed
    28
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Doxapram
    Reporting group description
    		 Group receiving doxapram

    Reporting group title
    Placebo
    Reporting group description
    		 Group receiving placebo

    Reporting group values
    		 Doxapram Placebo Total
    Number of subjects
    		 28 28 56
    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)
    		 12 15 27
        From 65-84 years
    		 16 13 29
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 51 (19 to 70) 48 (20 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 11 12 23
        Male
    		 17 16 33
    Subject analysis sets

    Subject analysis set title
    Doxapram
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Group that received doxapram

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Group that received placebo

    Subject analysis sets values
    		 Doxapram Placebo
    Number of subjects
    28
    28
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    12
    15
        From 65-84 years
    16
    13
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    51 (19 to 70)
    48 (20 to 68)
    Gender categorical
    Units: Subjects
        Female
    11
    12
        Male
    17
    16

    End points

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    End points reporting groups
    Reporting group title
    Doxapram
    Reporting group description
    		 Group receiving doxapram

    Reporting group title
    Placebo
    Reporting group description
    		 Group receiving placebo

    Subject analysis set title
    Doxapram
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Group that received doxapram

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Group that received placebo

    Primary: apnoeic apisodes

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    End point title
    		 apnoeic apisodes
    End point description
    PAtient stops breathing for 30 seconds
    End point type
    Primary
    End point timeframe
    during the procedure
    End point values
    		 Doxapram Placebo Doxapram Placebo
    Number of subjects analysed
    28
    28
    Units: n
    11
    17
    11
    17
    Statistical analysis title
    		 apnoeic episodes
    Comparison groups
    Doxapram v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18
    Method
    		 Fisher exact
    Confidence interval

    Primary: Hypoxemia

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    End point title
    		 Hypoxemia
    End point description
    peripheral oxygen saturation < 88%
    End point type
    Primary
    End point timeframe
    during the procedure
    End point values
    		 Doxapram Placebo Doxapram Placebo
    Number of subjects analysed
    28
    28
    28
    28
    Units: n
    8
    5
    8
    5
    Statistical analysis title
    		 hypoxemia
    Comparison groups
    Doxapram v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    during the procedure
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Adverse events that were encountered were apnoeic episodes and hypoxemia, which were the end points.

    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
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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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