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    Clinical Trial Results:
    Influence of sevoflurane and propofol on maximum muscular strength, speed of contraction and relaxation, in humans: A pilot study.

    Summary
    EudraCT number
    		 2022-003737-19
    Trial protocol
    		 BE  
    Global end of trial date
    27 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2024
    First version publication date
    27 Jul 2024
    Other versions
    Summary report(s)
    		 Statistical Methodology

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUB-ITF-sevo-propofol
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Brugmann
    Sponsor organisation address
    4 Place Arthur Van Gehuchten , Brussels, Belgium, 1020
    Public contact
    Anesthesiology Department, CHU Brugmann, 32 24773996, Christianerebecca.DZECHI@chu-brugmann.be
    Scientific contact
    Anesthesiology Department, CHU Brugmann, 32 24773996, Christianerebecca.DZECHI@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
    27 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In this study, we want to measure the influence of sevoflurane and propofol on the maximum force, maximum speed of contraction and relaxation at the adductor pollicis (muscle of the thumb).
    Protection of trial subjects
    Sevoflurane is an anesthetic gas routinely used during surgical procedures to maintain anesthesia in patients. Propofol is an intravenous anesthesia product used either to induce anesthesia or to maintain anesthesia during surgery. These two drugs are used in almost all standard of care anesthesia. The study intervention consists of muscle strength measurement using the ITF (Isometric Thumb Force) device. This involves pushing with the thumb on a sensor that measures the force developed. This procedure does not cause pain or distress.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2023
    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: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    46
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were approached at the outpatient pre-anesthetic visit of the CHU Brugmann Hospital (Brussels, Belgium). The patient could decide up to the day of their surgery to participate in the study or not. Surgery dates ranged from 06 February 2023 till 27 April 2023.

    Pre-assignment
    Screening details
    		 Patients were screened at the outpatient pre-anesthetic visit of the CHU Brugmann Hospital (Brussels, Belgium) for inclusion/exclusion criteria. ICF was given and the patient could decide up to the day of their surgery to participate in the study or not.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Assessor
    Blinding implementation details
    Patients are randomized in a 1:1 ration (block randomization of 4) to receive either sevoflurane or propofol for maintenance of anesthesia. Groups are put in sealed and opaque envelopes, opened after inclusion by the anesthesiologist in charge of the patient. The member of the study team explaining the procedure, and making the measurements, is blinded to the treatment group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sevoflurane
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sevorane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    4%, inhalation use

    Arm title
    		 Propofol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diprivan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    10mg/kg/h, infusion

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is an assessor-blinded trial. The patient is blind to the anesthetic used (sevoflurane or propofol). The anesthesiologist in charge of the patient is aware of the anesthetic used, but the staff performing the measurements of maximum force, maximum contraction speed and maximum relaxation speed of the adductor pollicis (muscle of the thumb) is blinded.
    Number of subjects in period 1
    		Sevoflurane Propofol
    Started
    24
    24
    Completed
    20
    20
    Not completed
    4
    4
         Adverse event, non-fatal
    -
    1
         Anesthesia duration too short
    3
    -
         Protocol deviation
    1
    3

    Baseline characteristics

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

    Reporting group title
    Propofol
    Reporting group description
    		 -

    Reporting group values
    		 Sevoflurane Propofol Total
    Number of subjects
    		 24 24 48
    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)
    		 22 24 46
        From 65-84 years
    		 2 0 2
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 14 14 28
        Male
    		 10 10 20

    End points

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

    Reporting group title
    Propofol
    Reporting group description
    		 -

    Primary: Preoperative maximum force

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    End point title
    		 Preoperative maximum force [1]
    End point description
    End point type
    Primary
    End point timeframe
    Before anesthesia by either sevoflurane or propofol
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is detailed in the pdf file in annex. There was no statistically significant differences, neither in the intragroup analysis (pre versus postoperative values in each group), nor in the intergroup analysis (propofol versus sevoflurane).
    End point values
    		 Sevoflurane Propofol
    Number of subjects analysed
    20
    20
    Units: newton
        median (inter-quartile range (Q1-Q3))
    44.46 (32.22 to 64.94)
    45.02 (33.05 to 63.82)
    No statistical analyses for this end point

    Primary: Postoperative maximum force

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    End point title
    		 Postoperative maximum force [2]
    End point description
    End point type
    Primary
    End point timeframe
    After anesthesia by either sevoflurane or propofol
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is detailed in the pdf file in annex. There was no statistically significant differences, neither in the intragroup analysis (pre versus postoperative values in each group), nor in the intergroup analysis (propofol versus sevoflurane).
    End point values
    		 Sevoflurane Propofol
    Number of subjects analysed
    20
    20
    Units: newton
        median (inter-quartile range (Q1-Q3))
    51.99 (33.39 to 64.79)
    42.40 (35.37 to 56.63)
    No statistical analyses for this end point

    Primary: Postoperative maximum contraction speed

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    End point title
    		 Postoperative maximum contraction speed [3]
    End point description
    End point type
    Primary
    End point timeframe
    After anesthesia by either sevoflurane or propofol
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is detailed in the pdf file in annex. There was no statistically significant differences, neither in the intragroup analysis (pre versus postoperative values in each group), nor in the intergroup analysis (propofol versus sevoflurane).
    End point values
    		 Sevoflurane Propofol
    Number of subjects analysed
    20
    20
    Units: newton/second
        median (inter-quartile range (Q1-Q3))
    224.06 (140.47 to 414.52)
    177.10 (136.36 to 252.98)
    No statistical analyses for this end point

    Primary: Preoperative maximum relaxation speed

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    End point title
    		 Preoperative maximum relaxation speed [4]
    End point description
    End point type
    Primary
    End point timeframe
    Before anesthesia by either sevoflurane or propofol
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is detailed in the pdf file in annex. There was no statistically significant differences, neither in the intragroup analysis (pre versus postoperative values in each group), nor in the intergroup analysis (propofol versus sevoflurane).
    End point values
    		 Sevoflurane Propofol
    Number of subjects analysed
    20
    20
    Units: newton/second
        median (inter-quartile range (Q1-Q3))
    -416.79 (-634.77 to -279.31)
    -486.61 (-677.49 to -408.78)
    No statistical analyses for this end point

    Primary: Postoperative maximum relaxation speed

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    End point title
    		 Postoperative maximum relaxation speed [5]
    End point description
    End point type
    Primary
    End point timeframe
    After anesthesia by either sevoflurane or propofol
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is detailed in the pdf file in annex. There was no statistically significant differences, neither in the intragroup analysis (pre versus postoperative values in each group), nor in the intergroup analysis (propofol versus sevoflurane).
    End point values
    		 Sevoflurane Propofol
    Number of subjects analysed
    20
    20
    Units: newton/second
        median (inter-quartile range (Q1-Q3))
    -517.10 (-719.99 to -307.48)
    -468.50 (-609.88 to -309.32)
    No statistical analyses for this end point

    Primary: Preoperative maximum contraction speed

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    End point title
    		 Preoperative maximum contraction speed [6]
    End point description
    End point type
    Primary
    End point timeframe
    After anesthesia by either sevoflurane or propofol
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is detailed in the pdf file in annex. There was no statistically significant differences, neither in the intragroup analysis (pre versus postoperative values in each group), nor in the intergroup analysis (propofol versus sevoflurane).
    End point values
    		 Sevoflurane Propofol
    Number of subjects analysed
    20
    20
    Units: Newton/second
        median (inter-quartile range (Q1-Q3))
    223.49 (124.48 to 390.58)
    178.19 (140.47 to 341.93)
    No statistical analyses for this end point

    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
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Sevoflurane
    Reporting group description
    		 -

    Reporting group title
    Propofol
    Reporting group description
    		 -

    Serious adverse events
    		 Sevoflurane Propofol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (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
    		 Sevoflurane Propofol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    Nervous system disorders
    Anxiety
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1

    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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