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    Clinical Trial Results:
    Emergence times and airway reactions in general laryngeal mask airway anesthesia: a randomized multicenter controlled trial

    Summary
    EudraCT number
    		 2014-003810-96
    Trial protocol
    		 DE  
    Global end of trial date
    11 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2022
    First version publication date
    08 Jul 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    14-073
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02322502
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    RWTH Aachen University for the Medical Falculty, represented by Clinical Trial Center Aachen (CTC-A)
    Sponsor organisation address
    Pauwelsstr. 30, Aachen, Germany, 52074
    Public contact
    Center for Translational and Clinical Trials Aachen (CTC-A), Uniklinik RWTH Aachen, +49 2418080092, ctc-a-spoqs@ukaachen.de
    Scientific contact
    Center for Translational and Clinical Trials Aachen (CTC-A), Uniklinik RWTH Aachen, +49 2418080092, ctc-a-spoqs@ukaachen.de
    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
    24 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to assess if desflurane is superior in order to achieve a faster emergence from anesthesia (stating the date of birth)
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 2015
    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
    Germany: 352
    Worldwide total number of subjects
    352
    EEA total number of subjects
    352
    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)
    352
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment and treatment of subjects was performed in four trial centers. Overall 352 subjects were enrolled and randomized in the clinical trial in the timeframe from 26.02.2015 till 31.10.2015.

    Pre-assignment
    Screening details
    		 Overall 536 subjects were screened in four trial centers. Of those 536 subjects screened, 352 subjects met the inclusion and exclusion criteria and were enrolled.

    Period 1
    Period 1 title
    Anaesthesia induction till POD 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Desflurane
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Suprane
    Investigational medicinal product code
    IMP 1
    Other name
    DESFLURANE
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fresh gas flow 2l/min, setting vapor to 12 vol. % until the desired end-expiratory target concentration of 0.8 MAC (minimal alveolar concentration) / 4-5 vol. % desflurane is achieved, reduction of the fresh gas flow to 500-1000ml and adjusting desflurane concentration to maintain a BIS index value between 40 and 60.

    Arm title
    		 Sevoflurane
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevorane
    Investigational medicinal product code
    IMP 2
    Other name
    Sevoflurane
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Fresh gas flow 2l/min, setting vapor to 8 vol. % until the desired end-expiratory target concentration of 0.8 MAC / 1.2-1.4 vol. % sevoflurane is achieved, reduction of the fresh gas flow to 500-1000ml and adjusting desflurane concentration to maintain a BIS index value between 40 and 60.

    Arm title
    		 Propofol
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    IMP 3
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-7 mg kg-1 h-1 propofol adjusted to maintain a BIS index value between 40 and 60

    Number of subjects in period 1
    		Desflurane Sevoflurane Propofol
    Started
    118
    114
    120
    Completed
    118
    114
    120

    Baseline characteristics

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

    Reporting group title
    Sevoflurane
    Reporting group description
    		 -

    Reporting group title
    Propofol
    Reporting group description
    		 -

    Reporting group values
    		 Desflurane Sevoflurane Propofol Total
    Number of subjects
    		 118 114 120 352
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 52 (37.5 to 63) 50 (36 to 60.5) 51 (31 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 52 56 55 163
        Male
    		 66 58 65 189
    Smoking
    Units: Subjects
        Nonsmoker
    		 62 62 79 203
        ex-smoker
    		 16 15 13 44
        current smoker
    		 37 34 26 97
        missing data
    		 3 3 2 8
    ASA
    Units: Subjects
        Category I
    		 44 42 40 126
        Category II
    		 56 61 72 189
        Category III
    		 15 8 7 30
        missing data
    		 3 3 1 7
    No pre-existing disease
    Units: Subjects
        yes
    		 46 49 56 151
        no
    		 69 62 63 194
        missing data
    		 3 3 1 7
    Arterial hypertension
    Units: Subjects
        yes
    		 33 29 36 98
        no
    		 82 82 83 247
        missing data
    		 3 3 1 7
    Pulmonary disease
    Units: Subjects
        yes
    		 3 1 1 5
        no
    		 112 110 118 340
        missing data
    		 3 3 1 7
    Diabetes
    Units: Subjects
        yes
    		 11 9 8 28
        no
    		 104 102 111 317
        missing data
    		 3 3 1 7
    Renal disease
    Units: Subjects
        yes
    		 3 1 1 5
        no
    		 112 110 118 340
        missing data
    		 3 3 1 7
    Cerebrovascular disease
    Units: Subjects
        yes
    		 1 0 0 1
        no
    		 114 111 119 344
        missing data
    		 3 3 1 7
    Malignant disease
    Units: Subjects
        yes
    		 11 10 5 26
        no
    		 104 101 114 319
        missing data
    		 3 3 1 7
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 172.7 ± 9.7 172.6 ± 9.2 172.4 ± 9.1 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 78.5 ± 13 79.2 ± 14.1 78.2 ± 13.6 -
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 26.3 ± 3.7 26.5 ± 3.7 26.2 ± 3.6 -
    Current smokers - Pack years
    Units: cigarrette pack years
        arithmetic mean (standard deviation)
    		 18.9 ± 12 17.8 ± 19.7 16.1 ± 16 -

    End points

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

    Reporting group title
    Sevoflurane
    Reporting group description
    		 -

    Reporting group title
    Propofol
    Reporting group description
    		 -

    Primary: Time to state date of birth (TSB)

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    End point title
    		 Time to state date of birth (TSB)
    End point description
    End point type
    Primary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [1]
    111 [2]
    118 [3]
    Units: minute
        arithmetic mean (standard deviation)
    8.1 ± 3.6
    10.1 ± 4.0
    9.8 ± 5.1
    Notes
    [1] - 4 missing data
    [2] - 3 missing data
    [3] - 2 missing data
    Statistical analysis title
    		 Analysis TSB
    Comparison groups
    Desflurane v Propofol v Sevoflurane
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 ANOVA
    Confidence interval

    Secondary: Intraoperative coughs

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    End point title
    		 Intraoperative coughs
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        yes
    4
    1
    2
        no
    110
    110
    117
        missing data
    4
    3
    1
    Statistical analysis title
    		 Analysis intraoperative coughs
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Intraoperative laryngospasm

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    End point title
    		 Intraoperative laryngospasm
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        yes
    4
    3
    2
        no
    110
    108
    117
        missing data
    4
    3
    1
    Statistical analysis title
    		 Analysis intraoperative laryngospasm
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Cough at emergence

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    End point title
    		 Cough at emergence
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        yes
    1
    0
    0
        no
    113
    111
    118
        missing data
    4
    3
    2
    Statistical analysis title
    		 Analysis cough at emergence
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.38
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Laryngospasms at emergence

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    End point title
    		 Laryngospasms at emergence
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        yes
    2
    0
    0
        no
    112
    111
    119
        missing data
    4
    3
    1
    Statistical analysis title
    		 Analysis laryngospasm at emergence
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Time to remove laryngeal mask (TLR)

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    End point title
    		 Time to remove laryngeal mask (TLR)
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [4]
    111 [5]
    118 [6]
    Units: minute
        arithmetic mean (standard deviation)
    6.9 ± 3.3
    8.7 ± 3.9
    8.2 ± 4.1
    Notes
    [4] - 4 missing data
    [5] - 3 missing data
    [6] - 2 missing data
    Statistical analysis title
    		 Analysis TLR
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Confidence interval

    Secondary: Time to open eyes on command (TOE)

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    End point title
    		 Time to open eyes on command (TOE)
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [7]
    111 [8]
    119 [9]
    Units: minute
        arithmetic mean (standard deviation)
    6.8 ± 3.5
    8.6 ± 4.1
    8.0 ± 4.4
    Notes
    [7] - 4 missing data
    [8] - 3 missing data
    [9] - 1 missing data
    Statistical analysis title
    		 Analysis TOE
    Comparison groups
    Sevoflurane v Desflurane v Propofol
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 ANOVA
    Confidence interval

    Secondary: Time to respond to command (TRC)

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    End point title
    		 Time to respond to command (TRC)
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [10]
    111 [11]
    119 [12]
    Units: minute
        arithmetic mean (standard deviation)
    7.54 ± 3.6
    9.6 ± 4.1
    9.1 ± 4.9
    Notes
    [10] - 4 missing data
    [11] - 3 missing data
    [12] - 1 missing data
    Statistical analysis title
    		 Analysis TRC
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 ANOVA
    Confidence interval

    Secondary: Time to state full name on command (TSN)

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    End point title
    		 Time to state full name on command (TSN)
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [13]
    111 [14]
    119 [15]
    Units: minute
        arithmetic mean (standard deviation)
    8.0 ± 3.6
    9.9 ± 4.0
    9.7 ± 5.1
    Notes
    [13] - 4 missing data
    [14] - 3 missing data
    [15] - 1 missing data
    Statistical analysis title
    		 Analysis TSN
    Comparison groups
    Desflurane v Sevoflurane v Propofol
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 ANOVA
    Confidence interval

    Secondary: Recovery index

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    End point title
    		 Recovery index
    End point description
    End point type
    Secondary
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [16]
    111 [17]
    118 [18]
    Units: none
        arithmetic mean (standard deviation)
    0.6 ± 0.3
    0.5 ± 0.6
    0.6 ± 0.7
    Notes
    [16] - 4 missing data
    [17] - 3 missing data
    [18] - 2 missing data
    Statistical analysis title
    		 Analysis recovery index
    Comparison groups
    Sevoflurane v Desflurane
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.01
    Statistical analysis title
    		 Analysis recovery index
    Comparison groups
    Propofol v Desflurane
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.08

    Other pre-specified: Depth of anaesthesia (BIS)

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    End point title
    		 Depth of anaesthesia (BIS)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [19]
    111 [20]
    118 [21]
    Units: none
        arithmetic mean (standard deviation)
    42.2 ± 13.6
    46.0 ± 14.1
    43.4 ± 14.8
    Notes
    [19] - 4 missing data
    [20] - 3 missing data
    [21] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Non Invasive Blood Pressure (NIBP) - systolic

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    End point title
    		 Non Invasive Blood Pressure (NIBP) - systolic
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [22]
    111 [23]
    118 [24]
    Units: mmHg
        arithmetic mean (standard deviation)
    101.2 ± 18.9
    99.0 ± 17.0
    103.9 ± 18.9
    Notes
    [22] - 4 missing data
    [23] - 3 missing data
    [24] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Non Invasive Blood Pressure (NIBP) - diastolic

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    End point title
    		 Non Invasive Blood Pressure (NIBP) - diastolic
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [25]
    111 [26]
    118 [27]
    Units: mmHg
        arithmetic mean (standard deviation)
    57.5 ± 11.7
    58.0 ± 12.1
    61.0 ± 12.1
    Notes
    [25] - 4 missing data
    [26] - 3 missing data
    [27] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Heart rate

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    End point title
    		 Heart rate
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [28]
    111 [29]
    118 [30]
    Units: bpm
        arithmetic mean (standard deviation)
    57.6 ± 11.1
    57.0 ± 10.2
    56.8 ± 11.1
    Notes
    [28] - 4 missing data
    [29] - 3 missing data
    [30] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Requirement of catecholamines - epinephrine & norepinephrine

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    End point title
    		 Requirement of catecholamines - epinephrine & norepinephrine
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [31]
    111 [32]
    118 [33]
    Units: µg
    arithmetic mean (standard deviation)
        epinephrine
    0.5 ± 4.0
    0 ± 0
    1.0 ± 6.9
        norepinephrine
    40.4 ± 113.6
    27.4 ± 83.0
    19.5 ± 99.2
    Notes
    [31] - 4 missing data
    [32] - 3 missing data
    [33] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Requirement of catecholamines - caphedrine & theoadrenaline

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    End point title
    		 Requirement of catecholamines - caphedrine & theoadrenaline
    End point description
    Total amount of the mixture 2 ml caphedrine 200 mg and theoadrenaline 10 mg ad 8 ml sodium chloride
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [34]
    111 [35]
    118 [36]
    Units: ml
        arithmetic mean (standard deviation)
    1.3 ± 2.2
    1.4 ± 3.0
    0.9 ± 2.1
    Notes
    [34] - 4 missing data
    [35] - 3 missing data
    [36] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Airway pressures

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    End point title
    		 Airway pressures
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Anaesthesia induction till POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [37]
    111 [38]
    118 [39]
    Units: kPa
    arithmetic mean (standard deviation)
        Peak Pressure
    1.6 ± 0.4
    1.5 ± 0.4
    1.5 ± 0.3
        Plateau Pressure
    1.2 ± 0.4
    1.1 ± 0.4
    1.1 ± 0.4
        Positive End-Expiratory Pressure
    0.3 ± 0.2
    0.3 ± 0.2
    0.3 ± 0.2
    Notes
    [37] - 4 missing data
    [38] - 3 missing data
    [39] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: End-expiratory carbon dioxide

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    End point title
    		 End-expiratory carbon dioxide
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Positive EndExpiratory Pressure
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [40]
    111 [41]
    118 [42]
    Units: kPa
        arithmetic mean (standard deviation)
    5.1 ± 0.7
    5.1 ± 0.7
    4.9 ± 0.5
    Notes
    [40] - 4 missing data
    [41] - 3 missing data
    [42] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Aldrete score ≥ 9

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    End point title
    		 Aldrete score ≥ 9
    End point description
    End point type
    Other pre-specified
    End point timeframe
    5 min after LMA removal
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        yes
    94
    72
    74
        no
    20
    39
    41
        missing data
    4
    3
    2
    No statistical analyses for this end point

    Other pre-specified: VAS pain score

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    End point title
    		 VAS pain score
    End point description
    End point type
    Other pre-specified
    End point timeframe
    in the PACU
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [43]
    111 [44]
    118 [45]
    Units: score from 0-100
        arithmetic mean (standard deviation)
    28.8 ± 24.3
    27.7 ± 23.2
    25.2 ± 20.7
    Notes
    [43] - 4 missing data
    [44] - 3 missing data
    [45] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Frequency of vomiting

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    End point title
    		 Frequency of vomiting
    End point description
    End point type
    Other pre-specified
    End point timeframe
    in the PACU
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        yes
    3
    1
    0
        no
    111
    110
    118
        missing data
    4
    3
    2
    No statistical analyses for this end point

    Other pre-specified: Time to readiness to be discharged from PACU (Aldreete score ≥ 9)

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    End point title
    		 Time to readiness to be discharged from PACU (Aldreete score ≥ 9)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    in the PACU
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [46]
    111 [47]
    118 [48]
    Units: min
        arithmetic mean (standard deviation)
    8.1 ± 10.0
    11.1 ± 10.1
    13.3 ± 16.1
    Notes
    [46] - 4 missing data
    [47] - 3 missing data
    [48] - 2 missing data
    Statistical analysis title
    		 Analysis readiness - desflurane vs sevoflurane
    Comparison groups
    Desflurane v Sevoflurane
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 6.3
    Statistical analysis title
    		 Analysis readiness - desflurane vs propofol
    Comparison groups
    Propofol v Desflurane
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 8.2

    Other pre-specified: Total amount of additional applied propofol as rescue medication

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    End point title
    		 Total amount of additional applied propofol as rescue medication
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during surgery
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [49]
    111 [50]
    118 [51]
    Units: mg
        arithmetic mean (standard deviation)
    9.8 ± 44.4
    5.9 ± 17.7
    9.7 ± 50.8
    Notes
    [49] - 4 missing data
    [50] - 3 missing data
    [51] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Amount of wasted propofol

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    End point title
    		 Amount of wasted propofol
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during surgery
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [52]
    111 [53]
    118 [54]
    Units: mg
    0
    0
    220
    Notes
    [52] - 4 missing data
    [53] - 3 missing data
    [54] - 2 missing data
    No statistical analyses for this end point

    Other pre-specified: Intraoperative remifentanil dose

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    End point title
    		 Intraoperative remifentanil dose
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during surgery
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [55]
    111 [56]
    118 [57]
    Units: µg kg-1 min-1
        arithmetic mean (standard deviation)
    0.15 ± 0.1
    0.15 ± 0.1
    0.15 ± 0.1
    Notes
    [55] - 4 missing data
    [56] - 3 missing data
    [57] - 2 missing data
    Statistical analysis title
    		 Analysis Remifentanil - desflurane vs sevoflurane
    Comparison groups
    Desflurane v Sevoflurane
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0002
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.006
         upper limit
    		 0.005
    Statistical analysis title
    		 Analysis Remifentanil - desflurane vs propofol
    Comparison groups
    Desflurane v Propofol
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.002
         upper limit
    		 0.009

    Other pre-specified: Duration of anaesthesia

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    End point title
    		 Duration of anaesthesia
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during surgery
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [58]
    111 [59]
    118 [60]
    Units: min
        arithmetic mean (standard deviation)
    60.0 ± 34.4
    53.7 ± 28.4
    57.8 ± 28.6
    Notes
    [58] - 4 missing data
    [59] - 3 missing data
    [60] - 2 missing data
    Statistical analysis title
    		 Analysis anaesthesia - desflurane vs sevoflurane
    Comparison groups
    Sevoflurane v Desflurane
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 1.8
    Statistical analysis title
    		 Analysis anaesthesia - desflurane vs propofol
    Comparison groups
    Propofol v Desflurane
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 7

    Other pre-specified: Surgery duration

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    End point title
    		 Surgery duration
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during surgery
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [61]
    111 [62]
    118 [63]
    Units: min
        arithmetic mean (standard deviation)
    45.7 ± 32.5
    40.1 ± 25.8
    39.6 ± 27.7
    Notes
    [61] - 4 missing data
    [62] - 3 missing data
    [63] - 2 missing data
    Statistical analysis title
    		 Analysis surgery - desflurane vs sevoflurane
    Comparison groups
    Sevoflurane v Desflurane
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.1
         upper limit
    		 1.8
    Statistical analysis title
    		 Analysis surgery - desflurane vs propofol
    Comparison groups
    Propofol v Desflurane
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.6
         upper limit
    		 2.2

    Other pre-specified: PQRS cognitive domain - surgery day

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    End point title
    		 PQRS cognitive domain - surgery day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    surgery day
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    20
    26
    31
        recovered
    73
    65
    64
        no data
    25
    23
    25
    No statistical analyses for this end point

    Other pre-specified: PQRS cognitive domain - POD 1

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    End point title
    		 PQRS cognitive domain - POD 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    8
    6
    13
        recovered
    76
    80
    80
        no data
    34
    28
    27
    No statistical analyses for this end point

    Other pre-specified: PQRS nociceptive domain - surgery day

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    End point title
    		 PQRS nociceptive domain - surgery day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    surgery day
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    79
    66
    57
        recovered
    35
    45
    49
        no data
    4
    3
    4
    No statistical analyses for this end point

    Other pre-specified: PQRS nociceptive domain - POD 1

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    End point title
    		 PQRS nociceptive domain - POD 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    57
    46
    51
        recovered
    54
    60
    64
        no data
    7
    8
    5
    No statistical analyses for this end point

    Other pre-specified: PQRS emotive domain - surgery day

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    End point title
    		 PQRS emotive domain - surgery day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    surgery day
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    22
    19
    12
        recovered
    92
    92
    104
        no data
    4
    3
    4
    No statistical analyses for this end point

    Other pre-specified: PQRS emotive domain - POD 1

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    End point title
    		 PQRS emotive domain - POD 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    18
    9
    11
        recovered
    93
    97
    104
        no data
    7
    8
    5
    No statistical analyses for this end point

    Other pre-specified: PQRS physiological domain - surgery day

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    End point title
    		 PQRS physiological domain - surgery day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    surgery day
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    37
    45
    46
        recovered
    77
    66
    70
        no data
    4
    3
    4
    No statistical analyses for this end point

    Other pre-specified: PQRS ADL domain - POD 1

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    End point title
    		 PQRS ADL domain - POD 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    25
    18
    20
        recovered
    85
    88
    94
        no data
    8
    8
    6
    No statistical analyses for this end point

    Other pre-specified: PQRS all domains - surgery day

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    End point title
    		 PQRS all domains - surgery day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    surgery day
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    93
    90
    92
        recovered
    17
    17
    19
        no data
    8
    7
    9
    No statistical analyses for this end point

    Other pre-specified: PQRS all domains - POD 1

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    End point title
    		 PQRS all domains - POD 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not recovered
    79
    61
    67
        recovered
    25
    33
    37
        no data
    14
    20
    16
    No statistical analyses for this end point

    Other pre-specified: PQRS overall patient perspective - POD 1

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    End point title
    		 PQRS overall patient perspective - POD 1
    End point description
    End point type
    Other pre-specified
    End point timeframe
    POD 1
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    118
    114
    120
    Units: subjects
        not at all impacted
    27
    29
    40
        minimally impacted
    23
    21
    23
        moderately impacted
    15
    23
    17
        severely impacted
    16
    12
    14
        completely impacted
    21
    17
    17
        no data
    16
    12
    9
    No statistical analyses for this end point

    Other pre-specified: Intraoperative piritramide

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    End point title
    		 Intraoperative piritramide
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during surgery
    End point values
    		 Desflurane Sevoflurane Propofol
    Number of subjects analysed
    114 [64]
    111 [65]
    118 [66]
    Units: mg
        arithmetic mean (standard deviation)
    5.5 ± 2.5
    5.2 ± 2.6
    4.7 ± 2.4
    Notes
    [64] - 4 missing data
    [65] - 3 missing data
    [66] - 2 missing data
    Statistical analysis title
    		 Analysis piritramide - desflurane vs sevoflurane
    Comparison groups
    Sevoflurane v Desflurane
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.4
    Statistical analysis title
    		 Analysis piritramide - desflurane vs propofol
    Comparison groups
    Propofol v Desflurane
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Desflurane
    Reporting group description
    		 -

    Reporting group title
    Sevoflurane
    Reporting group description
    		 -

    Reporting group title
    Propofol
    Reporting group description
    		 -

    Serious adverse events
    		 Desflurane Sevoflurane Propofol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 118 (1.69%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Hypotonia
         subjects affected / exposed
    2 / 118 (1.69%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Desflurane Sevoflurane Propofol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 118 (36.44%)
    40 / 114 (35.09%)
    38 / 120 (31.67%)
    Injury, poisoning and procedural complications
    Displacement of laryngeal mask, hypotonia, bradycardia
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Intraoperative cough
         subjects affected / exposed
    4 / 118 (3.39%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
         occurrences all number
    6
    2
    3
    intraoperative laryngospasm
         subjects affected / exposed
    4 / 118 (3.39%)
    3 / 114 (2.63%)
    2 / 120 (1.67%)
         occurrences all number
    5
    3
    2
    Cough at emergence
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngospasm at emergence
         subjects affected / exposed
    2 / 118 (1.69%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0
    0
    Cardiac disorders
    AV Block IIA
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    10 / 118 (8.47%)
    7 / 114 (6.14%)
    8 / 120 (6.67%)
         occurrences all number
    10
    7
    8
    Hypertension
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    1
    0
    1
    Hypertension intraoperative
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Hypotension
         subjects affected / exposed
    24 / 118 (20.34%)
    27 / 114 (23.68%)
    22 / 120 (18.33%)
         occurrences all number
    24
    27
    23
    Hypotension intraoperative
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotonia intraoperative
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    postoperative agitation
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Carbon dioxide increased
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Postoperative nausea and vomiting
         subjects affected / exposed
    1 / 118 (0.85%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
         occurrences all number
    1
    1
    0
    Shivering
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    1
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    perforated uterus
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Intubation
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Singultus
         subjects affected / exposed
    0 / 118 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29916859
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