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    Clinical Trial Results:
    Does isocapnic hyperventilation hasten early recovery with sevoflurane and desflurane in O2/air?

    Summary
    EudraCT number
    		 2014-000678-20
    Trial protocol
    		 BE  
    Global end of trial date
    06 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2025
    First version publication date
    04 May 2025
    Other versions
    Summary report(s)
    		 article study

    Trial information

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    Trial identification
    Sponsor protocol code
    SEVODESHV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussel
    Sponsor organisation address
    Laarbeeklaan 101, 1090, Belgium,
    Public contact
    Datanurse, UZ Brussel, +32 24763134, veerle.vanmossevelde@uzbrussel.be
    Scientific contact
    Datanurse, UZ Brussel, +32 24763134, veerle.vanmossevelde@uzbrussel.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
    17 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of the study is to examine the effect of hyperventilation on early recovery parameters when sevoflurane or desflurane is used. CO2 will be added to the inspired gas to avoid hypocapnia (“isocapnic hyperventilation”)
    Protection of trial subjects
    Trial subjects were closely monitored through the whole study conduct as from signing the informed consent. If heart rate or blood pressure increased 20% above baseline (immediate pre‐induction values) or systolic blood pressure increased above 140 mm Hg, Ce remifentanil was increased. Hypotension (systolic blood pressure ≤80 mm Hg) was treated by decreasing the Ce remifentanil (with a 1.5 ng/mL lower limit), additional fluid administration, and by intravenous phenylephrine or ephedrine, depending on the prevailing heart rate.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2014
    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: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 34
    Number of subjects completed
    		 25

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 no data captured: 9
    Period 1
    Period 1 title
    study conduct (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Normoventilation group
    Arm description
    		 -
    Arm type
    		 SOC Group

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Isocapnic hyperventilation group
    Arm description
    		 -
    Arm type
    		 test group

    Investigational medicinal product name
    Respiratory rate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Unknown use
    Dosage and administration details
    respiratory rate was doubled for this group after anesthesia was stopped.

    Number of subjects in period 1 [1]
    		Normoventilation group Isocapnic hyperventilation group
    Started
    13
    12
    Completed
    13
    12
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 34 patients were enrolled (ICF signed) in the study. However 9 patients were lost due to failed data retrieval during surgery/anesthesia.

    Baseline characteristics

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

    Reporting group title
    Isocapnic hyperventilation group
    Reporting group description
    		 -

    Reporting group values
    		 Normoventilation group Isocapnic hyperventilation group Total
    Number of subjects
    		 13 12 25
    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
        arithmetic mean (standard deviation)
    		 56 ( 18 ) 47 ( 21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6 12
        Male
    		 7 6 13
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 166 ( 10 ) 170 ( 8 ) -
    weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 73 ( 13 ) 74 ( 14 ) -
    Lean body mass
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 51 ( 8 ) 52 ( 7 ) -
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 26 ( 4 ) 26 ( 5 ) -
    maintenance partial pressure sevoflurane
    Units: percent
        arithmetic mean (standard deviation)
    		 1.6 ( 0.02 ) 1.7 ( 0.05 ) -
    Maintenance Fa CO2
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 35 ( 3 ) 38 ( 2 ) -
    Emergence Fa CO2
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 37 ( 2 ) 39 ( 1 ) -
    duration anesthetic agent administration
    Units: minute
        arithmetic mean (standard deviation)
    		 128 ( 84 ) 150 ( 63 ) -
    duration anesthesia
    Units: minute
        arithmetic mean (standard deviation)
    		 133 ( 88 ) 157 ( 60 ) -
    duration remifentanil infusion
    Units: minute
        arithmetic mean (standard deviation)
    		 125 ( 85 ) 153 ( 64 ) -
    minute ventilation during maintenance
    Units: litre/minute
        arithmetic mean (standard deviation)
    		 4.2 ( 0.5 ) 5.3 ( 1.4 ) -
    minute ventilation during emergence
    Units: litre/minute
        arithmetic mean (standard deviation)
    		 4.2 ( 0.6 ) 10.7 ( 2.7 ) -
    tidal volume
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    		 429 ( 43 ) 478 ( 73 ) -
    respiratory rate maintenance
    Units: 1/minute
        arithmetic mean (standard deviation)
    		 10 ( 1 ) 10 ( 2 ) -
    respiratory rate emergence
    Units: 1/minute
        arithmetic mean (standard deviation)
    		 10 ( 1 ) 20 ( 4 ) -

    End points

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

    Reporting group title
    Isocapnic hyperventilation group
    Reporting group description
    		 -

    Primary: time to proper response to verbal command

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    End point title
    		 time to proper response to verbal command
    End point description
    End point type
    Primary
    End point timeframe
    Time from the beginning of emergence to proper response to verbal command.
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: minute
        arithmetic mean (standard deviation)
    9.9 ( 2.9 )
    7.6 ( 2.2 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: time to ETT removal

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    End point title
    		 time to ETT removal
    End point description
    End point type
    Primary
    End point timeframe
    Time from the beginning of emergence to ETT removal
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: minute
        arithmetic mean (standard deviation)
    11.0 ( 2.4 )
    7.6 ( 2.6 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Time to stating name

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    End point title
    		 Time to stating name
    End point description
    End point type
    Primary
    End point timeframe
    Time from the beginning of emergence to state name
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: minute
        arithmetic mean (standard deviation)
    12.5 ( 2.6 )
    8.9 ( 2.8 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Fa sevoflurane at T(eye)

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    End point title
    		 Fa sevoflurane at T(eye)
    End point description
    End point type
    Primary
    End point timeframe
    partial pressure of sevoflurane at time to proper respond to verbal command.
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: percent
        arithmetic mean (standard deviation)
    0.25 ( 0.16 )
    0.12 ( 0.12 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Fa sevo at T(ETT)

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    End point title
    		 Fa sevo at T(ETT)
    End point description
    End point type
    Primary
    End point timeframe
    partial pressure of sevoflurane at time to ETT removal.
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: percent
        arithmetic mean (standard deviation)
    0.23 ( 0.15 )
    0.12 ( 0.12 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Fa sevo T(name)

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    End point title
    		 Fa sevo T(name)
    End point description
    End point type
    Primary
    End point timeframe
    partial pressure of sevoflurane at time to stating name
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: percent
        arithmetic mean (standard deviation)
    0.19 ( 0.10 )
    0.11 ( 0.11 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Fa CO2 at T(eye)

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    End point title
    		 Fa CO2 at T(eye)
    End point description
    End point type
    Primary
    End point timeframe
    partial pressure of CO2 at time to proper respond to verbal command.
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: mm Hg
        arithmetic mean (standard deviation)
    38 ( 2 )
    39 ( 2 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Fa CO2 at T(ETT)

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    End point title
    		 Fa CO2 at T(ETT)
    End point description
    End point type
    Primary
    End point timeframe
    partial pressure of CO2 at time to ETT removal
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: mm Hg
        arithmetic mean (standard deviation)
    39 ( 4 )
    39 ( 2 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Fa CO2 at T(name)

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    End point title
    		 Fa CO2 at T(name)
    End point description
    End point type
    Primary
    End point timeframe
    partial pressure of CO2 at time to state name
    End point values
    		 Normoventilation group Isocapnic hyperventilation group
    Number of subjects analysed
    13
    12
    Units: mm Hg
        arithmetic mean (standard deviation)
    38 ( 3 )
    39 ( 3 )
    Statistical analysis title
    		 ANOVA + t-test
    Comparison groups
    Normoventilation group v Isocapnic hyperventilation group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    adverse events were to be reported as from signing the ICF till the time after surgery the patient could state their name. At that time point, the end of study was reached for every patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    study conduct
    Reporting group description
    		 -

    Serious adverse events
    		 study conduct
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 study conduct
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 33 (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 adverse events were reported because the study ended for the patient after they could state their name after surgery. On average this was 11-12 minutes after emergence.

    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
    For support, Contact us.
    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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