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    Clinical Trial Results:
    Propofol and etomidate. Are they also safe for patients with Brugada-Syndrome?

    Summary
    EudraCT number
    		 2012-000584-25
    Trial protocol
    		 BE  
    Global end of trial date
    31 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2021
    First version publication date
    21 May 2021
    Other versions
    Summary report(s)
    		 Published Article of Study

    Trial information

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    Trial identification
    Sponsor protocol code
    FLAM01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussels
    Sponsor organisation address
    Laarbeeklaan 101, Brussels, Belgium, 1090
    Public contact
    Anaesthesia Department, UZBrussel, 0032 24778926, panagiotis.flamee@me.com
    Scientific contact
    Anaesthesia Department, UZBrussel, 0032 24778926, panagiotis.flamee@me.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
    19 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to investigate whether commonly used hypnotic agents, propofol and etomidate, are also safe for patients with BrS.
    Protection of trial subjects
    The implantation was performed under general anesthesia. We reviewed the anesthetic chart of each patient investigating the occurrence of malignant arrhythmic events and the need for defibrillation during induction and maintenance of anesthesia. The choice of hypnotic agent and the dose administered for induction of anesthesia were registered. General anesthesia was conducted in an operating theater where an external cardioverter defibrillator was attached to the patient with adhesive pads prior to the procedure. The radial artery was cannulated for invasive blood pressure monitoring. Further monitoring of the patient comprised five-lead ECG, pulse oxymetry, and continuous carbon dioxide monitoring through side sampling from the ventilator tubes. Anesthesia was induced with propofol and sufentanyl. The airway was secured with a laryngeal mask or an endotracheal tube. In the latter, a muscle relaxant was administered in addition. Injection of propofol occurred in a single shot bolus—as often performed by most anesthetists—over a few seconds. Anesthesia was maintained with volatile anesthetics (sevoflurane or desflurane) in an oxygen-air mixture. Nitrous oxide was not used in this study. AICD implantation was performed by a cardiac surgeon via a nonthoracotomy transvenous lead system. Upon successful implantation of the AICD, defibrillation threshold testing was conducted and the wound was sutured. No local anesthetics were further administered. Statistics In this study, descriptive st
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2012
    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: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    3
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    48
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Since 1996, all patients diagnosed with BS and their relatives tested for the syndrome have been included in a registry and followed-up in a prospective fashion. BS was diagnosed clinically according to the modified task force criteria. Extended retrospective analysis of 429 patients with BS from the aforementioned database was performed.

    Pre-assignment
    Screening details
    		 During screening patients were checked if they had been diagnosed with Brugada Syndrome. An ECG would be taken and analysed by 3 cardiologist to determine if they had coved-type ST-segment elevation in the right precordial leads.

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

    Arms
    Arm title
    		 Group A
    Arm description
    		 Propofol is an anesthetic drug with a very attractive pharmacokinetic profile, which makes it the induction agent of choice, especially in day-case surgery. Data on its potential proarrhythmic effects in patients with Brugada syndrome (BS) patients are still lacking. The aim of our study was to investigate whether a single dose of propofol triggered any adverse events in consecutive high-risk patients with BS. All consecutive patients with BS having undergone an implantable cardiac defibrillator implantation under general anesthesia were eligible for this study. The anesthetic chart of each patient was reviewed, and the occurrence of malignant arrhythmic events as well as the need for defibrillation during induction and maintenance of anesthesia was investigated. Further monitoring of the patient comprised five-lead electrocardiogram (ECG), pulse oxymetry, and continuous carbon dioxide monitoring through side sampling from the ventilator tubes.
    Arm type
    		 Standard therapy

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    dose ranged between 0.8 mg/kg and 5.0 mg/kg

    Investigational medicinal product name
    sufentanyl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    0.5% - 8% via oxygen mask

    Number of subjects in period 1
    		Group A
    Started
    57
    Completed
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 57 57
    Age categorical
    Patients ranging van 6 years old till 85 years old.
    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)
    		 3 3
        Adolescents (12-17 years)
    		 2 2
        Adults (18-64 years)
    		 48 48
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
        All patients
    		 0 0
    Gender categorical
    All genders
    Units: Subjects
        Female
    		 22 22
        Male
    		 35 35

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Propofol is an anesthetic drug with a very attractive pharmacokinetic profile, which makes it the induction agent of choice, especially in day-case surgery. Data on its potential proarrhythmic effects in patients with Brugada syndrome (BS) patients are still lacking. The aim of our study was to investigate whether a single dose of propofol triggered any adverse events in consecutive high-risk patients with BS. All consecutive patients with BS having undergone an implantable cardiac defibrillator implantation under general anesthesia were eligible for this study. The anesthetic chart of each patient was reviewed, and the occurrence of malignant arrhythmic events as well as the need for defibrillation during induction and maintenance of anesthesia was investigated. Further monitoring of the patient comprised five-lead electrocardiogram (ECG), pulse oxymetry, and continuous carbon dioxide monitoring through side sampling from the ventilator tubes.

    Primary: Number of arrhythmias

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    End point title
    		 Number of arrhythmias [1]
    End point description
    End point type
    Primary
    End point timeframe
    Hours during operation
    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: Only descriptive statistics were used and values are reported in mean +- standard deviation. In case of proportions, the absolute numbers were reported followed by percentages. There was no statistical test performed between to groups.
    End point values
    		 Group A
    Number of subjects analysed
    57
    Units: number of arrhytmias
    57
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For maximum a week post operation. Until hospital discharge.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Total group
    Reporting group description
    		 -

    Serious adverse events
    		 Total group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Total group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
    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: No patient developed a malignant rhythm during induction and maintenance of anesthesia. All patients were then safely discharged from the postanesthetic care unit after 1 hour. No adverse events were noticed during the recovery phase. Subsequent to 24 hours of monitoring, patients left the hospital in good condition.

    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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