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    Clinical Trial Results:
    The effect of desflurane versus Sevoflurane on postoperative recovery in patients undergoing minor- to moderate-risk noncardiac surgery - a prospective double-blinded randomized clinical trial

    Summary
    EudraCT number
    		 2022-000556-11
    Trial protocol
    		 AT  
    Global end of trial date
    01 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Oct 2024
    First version publication date
    18 Oct 2024
    Other versions
    Summary report(s)
    		 Publication
    SAE Report

    Trial information

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    Trial identification
    Sponsor protocol code
    RAPID_01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05331027
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Head Office, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, 0043 4040041020, sekretariat-anaesthesie@meduniwien.ac.at
    Scientific contact
    Head Office, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, 0043 4040041020, sekretariat-anaesthesie@meduniwien.ac.at
    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
    25 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Our primary outcome will be the time (in minutes) from discontinuation of volatile anesthetic at the end of surgery until a modified Aldrete score of ≥ 12 points will be reached. We will start to assess postoperative recovery using the modified Aldrete score after arrival at the postoperative care unit (PACU) and thereafter in five minutes intervals. The score consists of 7 modalities (Activity, Respiration, Circulation, Consciousness, Oxygenation, Pain and Emetic Symptoms) with a score of 0-2 points in each criterion.
    Protection of trial subjects
    Patients received desflurane or sevoflurane for general anesthesia. Both anesthetics are commonly used for anesthesia. Thus, there is a low risk for subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2022
    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
    Austria: 190
    Worldwide total number of subjects
    190
    EEA total number of subjects
    190
    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)
    0
    From 65 to 84 years
    176
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study personnel screened surgical schedule a day before surgery. If patients meeting the inclusion criteria a study physician performed informed consent also a day before surgery.

    Pre-assignment
    Screening details
    		 Patients were eligible if they were at least 65 years undergoing a minor- to moderate-risk noncardiac surgery.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Subjects were not aware of the allocated randomization.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Desflurane
    Arm description
    		 Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desflurane
    Investigational medicinal product code
    N01AB07
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Maximum of 15% inspiratory concentration %(V/V) percent volume/volume

    Arm title
    		 Sevoflurane
    Arm description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    N01AB08
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    maximum of 6% inspiratory concentration %(V/V) percent volume/volume

    Number of subjects in period 1
    		Desflurane Sevoflurane
    Started
    95
    95
    Completed
    95
    95
    Period 2
    Period 2 title
    Intraoperative
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Subject was unaware of the randomly assigned group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sevoflurane
    Arm description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    N01AB08
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    maximum concentration of 6%, %(V/V) percent volume/volume

    Arm title
    		 Desflurane
    Arm description
    		 Patients randomly assigned to desflurane received desflurane for general anesthesia.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desflurane
    Investigational medicinal product code
    N01AB07
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    maximum of 15% inspiratory concentration %(V/V) percent volume/volume

    Number of subjects in period 2
    		Sevoflurane Desflurane
    Started
    95
    95
    Completed
    95
    95
    Period 3
    Period 3 title
    Outcome assessment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Assessor
    Blinding implementation details
    Outcome assessor and subject were unaware of the randomly assigned group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Desflurane
    Arm description
    		 Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desflurane
    Investigational medicinal product code
    N01AB07
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Maximum of 15% inspiratory concentration %(V/V) percent volume/volume

    Arm title
    		 Sevoflurane
    Arm description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    N01AB08
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    maximum of 6% inspiratory concentration %(V/V) percent volume/volume

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Only observer were blinded, treating physicians were not blinded.
    Number of subjects in period 3
    		Desflurane Sevoflurane
    Started
    95
    95
    Completed
    95
    95

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desflurane
    Reporting group description
    		 Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation.

    Reporting group values
    		 Desflurane Sevoflurane Total
    Number of subjects
    		 95 95 190
    Age categorical
    Units: Subjects
        From 65-84 years
    		 88 88 176
        85 years and over
    		 7 7 14
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 73 (70 to 80) 73 (70 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 44 46 90
        Male
    		 51 49 100

    End points

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    End points reporting groups
    Reporting group title
    Desflurane
    Reporting group description
    		 Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation.
    Reporting group title
    Sevoflurane
    Reporting group description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia.

    Reporting group title
    Desflurane
    Reporting group description
    		 Patients randomly assigned to desflurane received desflurane for general anesthesia.
    Reporting group title
    Desflurane
    Reporting group description
    		 Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation.

    Primary: Primary Outcome

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    End point title
    		 Primary Outcome
    End point description
    Anesthesia recovery, which was defined as the arrival at the PACU until discharge criteria were reached (Aldrete score more than 12) for a maximum of 2 hours.
    End point type
    Primary
    End point timeframe
    Anesthesia recovery
    End point values
    		 Desflurane Sevoflurane
    Number of subjects analysed
    95 [1]
    95 [2]
    Units: Duration of PACU stay
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [1] - intention-to-treat analysis
    [2] - intention-to-treat analysis
    Statistical analysis title
    		 Primary outcome
    Statistical analysis description
    For the primary outcome a Wilcoxon-signed rank test was used.
    Comparison groups
    Desflurane v Sevoflurane
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    first three postoperative days
    Adverse event reporting additional description
    File with SAE was attached.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: File with SAE and publication was attached.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39121786
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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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