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    Clinical Trial Results:
    Study: Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?

    Summary
    EudraCT number
    		 2016-002210-46
    Trial protocol
    		 NL  
    Global end of trial date
    27 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2020
    First version publication date
    05 Jul 2020
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    LiSA
    Additional study identifiers
    ISRCTN number
    		 ISRCTN47787339
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud University Medical Centre
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525 GA
    Public contact
    Twan Aalbers, RadboudUMC, 0031 243614406, twan.aalbers@radboudumc.nl
    Scientific contact
    Twan Aalbers, RadboudUMC, 0031 243614406, twan.aalbers@radboudumc.nl
    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
    18 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    te evaluate whether continuous infusion of lidocaïne reduces the need for alfentanyl in diagnostic colonoscopy in patients with Crohn disease or ulcerative colitis.
    Protection of trial subjects
    Patients will receive an intravenous line and are monitored with noninvasive systemic blood pressure, ECG, pulse oximetry and capnografy. Supplemental oxygen (3 L/min) is standardly administered by a nasal cannula. The Ramsey Sedation Scale scores will be maintained at 4-5 during colonoscopy and if needed, an additional 20 mg bolus of propofol is administered. The pain score is measured with the Facial Pain Rating Scale (Wong baker face scale). An additional alfentanyl dose of 0.25 mg is given when a score of 4 or higher is observed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    Netherlands: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    76
    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)
    76
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment period: 24-11-2016, end 13-11-2018 Participants were recruited at the preoperative outpatient clinic of the anesthesiology, radboudumc, the Netherlands.

    Pre-assignment
    Screening details
    		 All patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA, will be screened for this study. assessed for eligibility 137 patients

    Pre-assignment period milestones
    Number of subjects started
    		 76
    Number of subjects completed
    		 76

    Period 1
    Period 1 title
    end of trail (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Monitor
    Blinding implementation details
    Medication is drawn up into a 50 ml syringe on the surgical department by a qualified unblinded research team member immediately before administration and handed over to the physicain assistant.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natriumchloride 0,9 %,
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    The placebo group will receive saline in equivalent volumes and time as the intervention group: bolus 0.15 ml/kg followed by a continuous infusion of 0.2 ml/kg during colonoscopy

    Arm title
    		 lidocaine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lidocaïnehydrochloride 10 mg/ml
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    The intervention group receives lidocaine 1.5 mg/kg in 5 minutes followed by a continuous infusion of 2 mg/kg/hour body weight intravenously

    Number of subjects in period 1
    		placebo lidocaine
    Started
    38
    38
    Completed
    38
    38

    Baseline characteristics

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

    Reporting group title
    lidocaine
    Reporting group description
    		 -

    Reporting group values
    		 placebo lidocaine Total
    Number of subjects
    		 38 38 76
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 38 38 76
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38 ( 11 ) 37 ( 14 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 15 32
        Male
    		 21 23 44
    Disease
    Units: Subjects
        Crohn
    		 31 31 62
        Colitis ulcerosa
    		 7 7 14
    BMI
    Units: kg.m-2
        arithmetic mean (standard deviation)
    		 25.2 ( 4.3 ) 24.2 ( 3.1 ) -
    Duration of PSA
    Units: minutes
        arithmetic mean (standard deviation)
    		 33 ( 10 ) 32 ( 10 ) -
    Subject analysis sets

    Subject analysis set title
    placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo

    Subject analysis set title
    lidocaine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    lidocaine 1.5 mg/kg in 5 minutes followed by a continuous infusion of 2 mg/kg/hour body weight intravenously

    Subject analysis sets values
    		 placebo lidocaine
    Number of subjects
    38
    38
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    38
    38
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Disease
    Units: Subjects
        Crohn
        Colitis ulcerosa
    BMI
    Units: kg.m-2
        arithmetic mean (standard deviation)
    ( )
    ( )
    Duration of PSA
    Units: minutes
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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

    Reporting group title
    lidocaine
    Reporting group description
    		 -

    Subject analysis set title
    placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo

    Subject analysis set title
    lidocaine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    lidocaine 1.5 mg/kg in 5 minutes followed by a continuous infusion of 2 mg/kg/hour body weight intravenously

    Primary: Alfentanil dosage

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    End point title
    		 Alfentanil dosage
    End point description
    End point type
    Primary
    End point timeframe
    End of procedure
    End point values
    		 placebo lidocaine
    Number of subjects analysed
    38
    38
    Units: microgram(s)
        arithmetic mean (standard deviation)
    868 ( 647 )
    632 ( 519 )
    Statistical analysis title
    		 overall analysis
    Comparison groups
    placebo v lidocaine
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.082
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Propofol dosage

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    End point title
    		 Propofol dosage
    End point description
    End point type
    Secondary
    End point timeframe
    end of procedure
    End point values
    		 placebo lidocaine
    Number of subjects analysed
    38
    38
    Units: milligram(s)
        arithmetic mean (standard deviation)
    387 ( 106 )
    349 ( 85 )
    Statistical analysis title
    		 propofol
    Statistical analysis description
    propofol dosage
    Comparison groups
    placebo v lidocaine
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.095
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: hypoxia

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    End point title
    		 hypoxia
    End point description
    End point type
    Secondary
    End point timeframe
    end of procedure
    End point values
    		 placebo lidocaine
    Number of subjects analysed
    38
    38
    Units: number of incidence
    10
    8
    Statistical analysis title
    		 hypoxia
    Statistical analysis description
    incidence of hypoxia, An oxygen desaturation below 92% or interventions with the intention of improving the oxygen saturation will be recorded as an adverse event.[13] These interventions include the following: ‐ Vigorous tactile stimulation ‐ Airway repositioning ‐ Suctioning ‐ Increased oxygen delivery ‐ Oral or nasal airway placement ‐ Application of positive pressure or ventilation with bag mask
    Comparison groups
    placebo v lidocaine
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.788
    Method
    		 Chi-squared
    Confidence interval

    Secondary: hypotension

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    End point title
    		 hypotension
    End point description
    End point type
    Secondary
    End point timeframe
    end of procedure
    End point values
    		 placebo lidocaine
    Number of subjects analysed
    38
    38
    Units: number of incidence
    0
    0
    No statistical analyses for this end point

    Secondary: postcolonoscopy pain

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    End point title
    		 postcolonoscopy pain
    End point description
    End point type
    Secondary
    End point timeframe
    end of procedure
    End point values
    		 placebo lidocaine
    Number of subjects analysed
    38
    38
    Units: NRS score
        arithmetic mean (full range (min-max))
    0 (0 to 8)
    0 (0 to 8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from start of procedure to at least 30 minutes after procedure
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 castor
    Dictionary version
    1
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group title
    lidocaine
    Reporting group description
    		 -

    Serious adverse events
    		 placebo lidocaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 placebo lidocaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 38 (26.32%)
    8 / 38 (21.05%)
    Respiratory, thoracic and mediastinal disorders
    hypoxia
    Additional description: SpO2 < 92 %
         subjects affected / exposed
    10 / 38 (26.32%)
    8 / 38 (21.05%)
         occurrences all number
    38
    38

    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.
    Procedures were performed by several endoscopist and we did not include technically difficulty as a variable since this can be related to uncomfortable procedure.(22) This could have influenced our conclusions regarding the effect of lidocaine on al
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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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