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    Clinical Trial Results:
    Efficacy and safety of xenon anaesthesia compared to sevoflurane anaesthesia and total intravenous anaesthesia for on-pump coronary artery bypass graft surgery: a randomised, three-arm, single-blind, international study.

    Summary
    EudraCT number
    		 2010-020677-17
    Trial protocol
    		 NL   DE  
    Global end of trial date
    05 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 Publication_CABG_Anesthesiology_2018

    Trial information

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    Trial identification
    Sponsor protocol code
    ALMED-09-C3-026
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01294163
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Air Liquide Santé International
    Sponsor organisation address
    75, quai d'Orsay, Paris, France, 75007
    Public contact
    Healthcare Communication, Air Liquide Santé International, fralsi-publicontact@airliquide.com
    Scientific contact
    Clinical Development Physician, Air Liquide Santé International, fralsi-ctpublication@airliquide.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
    07 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of xenon anaesthesia on the postoperative blood level of cardiac troponin _ a predictive marker of medium - and long term clinical outcome after coronary artery bypass graft surgery _ 24 hours after the end of intervention, compared to sevoflurane anaesthesia and total intravenous anaesthesia.
    Protection of trial subjects
    The study was conducted in compliance with Good Clinical Practice guidelines, and in keeping with the most recent revised version of the Declaration of Helsinki (Seoul, 2008), and in the European Directive 2001/20/CE on 4th April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of the clinical trials on medicinal products for human use. The protocol and substantial amendments were submitted to the local ethics committee and competent authority for approval, in each country. The enrolment of the patients in the study started in a given participating country only after the written approvals of the corresponding national ethics committee and competent authority. There was no formal safety monitoring committee in this study, but for every 80 patients that underwent the surgical procedure, the Sponsor and the Study Chairman reviewed the rates of death by group to ensure that the incidence of death was as expected. A 2-sided 95% exact confidence interval (CI) was calculated for the proportion of deaths in the xenon, sevoflurane and TIVA groups at each review. If the lower range of the 95% CI in the xenon group was greater than the upper range of at least one of the two 2-sided 95% CI is calculated as described above, the trial was to be put on hold and further investigations were to be conducted on the study data to re-assess the benefit-risk ratio of xenon in the context of this study. This criterion was not met at any of the assessments so the trial continued. 
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2011
    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
    Netherlands: 36
    Country: Number of subjects enrolled
    France: 305
    Country: Number of subjects enrolled
    Germany: 189
    Country: Number of subjects enrolled
    Italy: 12
    Worldwide total number of subjects
    542
    EEA total number of subjects
    542
    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)
    266
    From 65 to 84 years
    276
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 542 patients were enrolled (492 patients were randomised and treated and 17 pilot patients were treated with Xenon but only analysed for safety) from 17 centres in 4 countries; 8 sites in France, 6 sites in Germany, 1 site in Italy and 2 sites in The Netherlands. Date of first enrolment: 20 April 2011 Date of last completed: 05 April 2014

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 542
    Number of subjects completed
    		 492

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Xenon pilot patients only analysed for safety: 17
    Reason: Number of subjects
    		 At least 1 Selection/Inclusion criterion not met: 17
    Reason: Number of subjects
    		 Investigator not available: 1
    Reason: Number of subjects
    		 Technical problem with ventilator: 1
    Reason: Number of subjects
    		 Surgical proc. postponed/cancelled/not eligible: 14
    Period 1
    Period 1 title
    Overall trial (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
    		 Xenon - ITT
    Arm description
    		 Anesthetic agent before and after cardiopulmonary bypass: xenon ITT – Intent-to-treat, i.e all randomised patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xenon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicinal gas, liquefied
    Routes of administration
    Inhalation use
    Dosage and administration details
    Maximal inspired concentration of 65%

    Arm title
    		 Sevoflurane - ITT
    Arm description
    		 Anesthetic agent before and after cardiopulmonary bypass: sevoflurane ITT – Intent-to-treat, i.e all randomised patients
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Maximal inspired concentration of 1.8%

    Arm title
    		 TIVA - ITT
    Arm description
    		 TIVA = Total intravenous anaesthesia Anesthetic agent before and after cardiopulmonary bypass: propofol ITT – Intent-to-treat, i.e all randomised patients
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Hourly dose of 2-4 mg/kg

    Number of subjects in period 1 [1]
    		Xenon - ITT Sevoflurane - ITT TIVA - ITT
    Started
    161
    165
    166
    Completed
    160
    165
    163
    Not completed
    1
    0
    3
         Adverse event, serious fatal
    -
    -
    3
         Adverse event, non-fatal
    1
    -
    -
    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: 542 patients signed an informed consent. 492 patients were randomised and treated

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Xenon - ITT
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: xenon ITT – Intent-to-treat, i.e all randomised patients

    Reporting group title
    Sevoflurane - ITT
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: sevoflurane ITT – Intent-to-treat, i.e all randomised patients

    Reporting group title
    TIVA - ITT
    Reporting group description
    		 TIVA = Total intravenous anaesthesia Anesthetic agent before and after cardiopulmonary bypass: propofol ITT – Intent-to-treat, i.e all randomised patients

    Reporting group values
    		 Xenon - ITT Sevoflurane - ITT TIVA - ITT Total
    Number of subjects
    		 161 165 166 492
    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)
    		 64.66 ( 9.12 ) 63.86 ( 8.66 ) 63.89 ( 9.40 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 25 20 64
        Male
    		 142 140 146 428
    BMI
    BMI = Body Mass Index
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 27.65 ( 3.64 ) 27.21 ( 3.68 ) 27.78 ( 4.00 ) -
    Subject analysis sets

    Subject analysis set title
    Xenon - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PP= per protocol Randomised patients who were treated with Xenon and who had no major deviations during the study.

    Subject analysis set title
    Sevoflurane - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PP= per protocol Randomised patients who were treated with Sevoflurane and who had no major deviations during the study.

    Subject analysis set title
    TIVA - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PP= per protocol Randomised patients who were treated with Propofol and who had no major deviations during the study.

    Subject analysis sets values
    		 Xenon - PP Sevoflurane - PP TIVA - PP
    Number of subjects
    146
    151
    149
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.51 ( 9.35 )
    63.70 ( 8.82 )
    63.84 ( 9.37 )
    Gender categorical
    Units: Subjects
        Female
    18
    24
    17
        Male
    128
    127
    132
    BMI
    BMI = Body Mass Index
    Units: kg/m²
        arithmetic mean (standard deviation)
    27.67 ( 3.69 )
    27.25 ( 3.75 )
    27.61 ( 3.91 )

    End points

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    End points reporting groups
    Reporting group title
    Xenon - ITT
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: xenon ITT – Intent-to-treat, i.e all randomised patients

    Reporting group title
    Sevoflurane - ITT
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: sevoflurane ITT – Intent-to-treat, i.e all randomised patients

    Reporting group title
    TIVA - ITT
    Reporting group description
    		 TIVA = Total intravenous anaesthesia Anesthetic agent before and after cardiopulmonary bypass: propofol ITT – Intent-to-treat, i.e all randomised patients

    Subject analysis set title
    Xenon - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PP= per protocol Randomised patients who were treated with Xenon and who had no major deviations during the study.

    Subject analysis set title
    Sevoflurane - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PP= per protocol Randomised patients who were treated with Sevoflurane and who had no major deviations during the study.

    Subject analysis set title
    TIVA - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PP= per protocol Randomised patients who were treated with Propofol and who had no major deviations during the study.

    Primary: Blood level of Troponin I

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    End point title
    		 Blood level of Troponin I
    End point description
    Blood level of Troponin I (cTnI ) measured by a central laboratory.
    End point type
    Primary
    End point timeframe
    Sampling performed 24 hours after the end of the surgical procedure.
    End point values
    		 Xenon - ITT Sevoflurane - ITT TIVA - ITT Xenon - PP Sevoflurane - PP TIVA - PP
    Number of subjects analysed
    161
    165
    166
    146
    151
    149
    Units: ng/ml
        arithmetic mean (standard deviation)
    2.33 ( 3.6 )
    2.66 ( 4.3 )
    3.40 ( 9.1 )
    2.12 ( 3.1 )
    2.59 ( 4.4 )
    2.90 ( 4.4 )
    Statistical analysis title
    		 Non-inferiority cTnI - Xenon and sevoflurane - PP
    Statistical analysis description
    PP = per protocol The primary comparison was a non-inferiority comparison of the xenon and sevoflurane groups in the PP. Distribution of cTnI concentrations being skewed with a right-tailed distribution, cTnI were transformed into log values.
    Comparison groups
    Xenon - PP v Sevoflurane - PP
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0186
    Method
    		 ANCOVA
    Parameter type
    		 LS-mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.11
    Notes
    [1] - The xenon group was considered non-inferior to the sevoflurane group if the upper bound of the adjusted two-sided 95% CI for the difference between the two mean log-transformed cTnI concentrations was less than the non-inferiority margin of 0.15ng/ml. LS-mean treatment difference and 95% CI were assessed using ANCOVA with cTnI (log-tranformed) as response, treatment group and pre-induction cTnI (log-transformed) as covariates.
    Statistical analysis title
    		 Non-inferiority cTnI - Xenon and sevoflurane - ITT
    Statistical analysis description
    Non-inferiority comparison of xenon vs sevoflurane was to be assessed in the ITT only if non-inferiority was demonstrated in the PP. Distribution of cTnI concentrations being skewed with a right-tailed distribution, cTnI were transformed into log values.
    Comparison groups
    Xenon - ITT v Sevoflurane - ITT
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.0136
    Method
    		 ANCOVA
    Parameter type
    		 LS-mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.1
    Notes
    [2] - The xenon group was considered non-inferior to the sevoflurane group if the upper bound of the adjusted two-sided 95% CI for the difference between the two mean log-transformed cTnI concentrations was less than the non-inferiority margin of 0.15ng/ml. LS-mean treatment difference and 95% CI were assessed using ANCOVA with cTnI (log-tranformed) as response, treatment group and pre-induction cTnI (log-transformed) as covariates.
    Statistical analysis title
    		 Superiority cTnI - Xenon and sevoflurane - ITT
    Statistical analysis description
    Superiority analysis was only to be performed if non-inferiority was demonstrated in both ITT and PP Sets. Distribution of cTnI concentrations being skewed with a right-tailed distribution, cTnI were transformed into log values.
    Comparison groups
    Xenon - ITT v Sevoflurane - ITT
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.316
    Method
    		 ANCOVA
    Parameter type
    		 LS-mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.1
    Notes
    [3] - LS-mean treatment difference and 95% CI were assessed using ANCOVA with cTnI (log-transformed) as response, treatment group and pre-induction cTnI (log-transformed) as covariates.
    Statistical analysis title
    		 Superiority cTnI - Xenon and sevoflurane - PP
    Statistical analysis description
    Superiority analysis was only to be performed if non-inferiority was demonstrated in both ITT and PP Sets. Distribution of cTnI concentrations being skewed with a right-tailed distribution, cTnI were transformed into log values.
    Comparison groups
    Xenon - PP v Sevoflurane - PP
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.3626
    Method
    		 ANCOVA
    Parameter type
    		 LS-mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.11
    Notes
    [4] - LS-mean treatment difference and 95% CI were assessed using ANCOVA with cTnI (log-transformed) as response, treatment group and pre-induction cTnI (log-transformed) as covariates.
    Statistical analysis title
    		 Superiority cTnI - Xenon and TIVA - ITT
    Statistical analysis description
    To check for assay sensitivity, superiority of xenon group over the TIVA group was also assessed. Distribution of cTnI concentrations being skewed with a right-tailed distribution, cTnI were transformed into log values.
    Comparison groups
    Xenon - ITT v TIVA - ITT
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.0452
    Method
    		 ANCOVA
    Parameter type
    		 LS-mean difference
    Point estimate
    -0.209
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4142
         upper limit
    		 -0.0045
    Notes
    [5] - LS-mean treatment difference and 95% CI were assessed using ANCOVA with cTnI (log-transformed) as response, treatment group and pre-induction cTnI (log-transformed) as covariates.
    Statistical analysis title
    		 Superiority cTnI - Sevoflurane and TIVA - ITT
    Statistical analysis description
    To check for assay sensitivity, superiority of sevoflurane group over the TIVA group was also assessed. Distribution of cTnI concentrations being skewed with a right-tailed distribution, cTnI were transformed into log values.
    Comparison groups
    Sevoflurane - ITT v TIVA - ITT
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.3268
    Method
    		 ANCOVA
    Parameter type
    		 LS-mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 0.1
    Notes
    [6] - LS-mean treatment difference and 95% CI were assessed using ANCOVA with cTnI (log-transformed) as response, treatment group and pre-induction cTnI (log-transformed) as covariates.

    Secondary: Other postoperative cardiac damage and prognostic markers: CK-MB Peak Concentration

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    End point title
    		 Other postoperative cardiac damage and prognostic markers: CK-MB Peak Concentration
    End point description
    The highest CK-MB (creatine kinase-MB fraction) postoperative value observed was derived.
    End point type
    Secondary
    End point timeframe
    Between ICU (Intensive Care Unit) admission and 48 hours after the end of the surgical procedure.
    End point values
    		 Xenon - ITT Sevoflurane - ITT TIVA - ITT
    Number of subjects analysed
    161
    164
    166
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    18 (10 to 25)
    18 (11 to 27)
    19 (11 to 30)
    No statistical analyses for this end point

    Secondary: Other postoperative cardiac damage and prognostic markers: CRP Peak Concentration

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    End point title
    		 Other postoperative cardiac damage and prognostic markers: CRP Peak Concentration
    End point description
    The highest CRP (C-reactive protein) postoperative value observed was derived.
    End point type
    Secondary
    End point timeframe
    Between ICU (Intensive Care Unit) admission and 48 hours after the end of the surgical procedure
    End point values
    		 Xenon - ITT Sevoflurane - ITT TIVA - ITT
    Number of subjects analysed
    160
    162
    166
    Units: mg/L
        median (inter-quartile range (Q1-Q3))
    181 (137 to 208)
    187 (156 to 229)
    195 (159 to 231)
    No statistical analyses for this end point

    Secondary: Other postoperative cardiac damage and prognostic markers: NT-proBNP Peak Concentration

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    End point title
    		 Other postoperative cardiac damage and prognostic markers: NT-proBNP Peak Concentration
    End point description
    The highest NT-proBNP (N-terminal-probrain naturetic protein) postoperative value observed was derived.
    End point type
    Secondary
    End point timeframe
    Between ICU (Intensive Care Unit) admission and 48 hours after the end of the surgical procedure
    End point values
    		 Xenon - ITT Sevoflurane - ITT TIVA - ITT
    Number of subjects analysed
    160
    163
    166
    Units: ng/L
        median (inter-quartile range (Q1-Q3))
    1614 (1035 to 2599)
    1508 (941 to 2209)
    1524 (912 to 2225)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events observed from the start of study treatment up to 30 days.
    Adverse event reporting additional description
    Participants at risk are the patients from the safety set. Multiple occurrences of a same adverse event (i.e. same preferred term) for a given patient are counted only once.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Xenon Including Pilot Patients
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: xenon This group is composed of all randomised and treated patients with xenon plus the first included and non randomised patients treated with xenon (xenon pilot patients) in each centre for investigator familiarisation.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: sevoflurane

    Reporting group title
    TIVA
    Reporting group description
    		 Anesthetic agent before and after cardiopulmonary bypass: propofol

    Serious adverse events
    		 Xenon Including Pilot Patients Sevoflurane TIVA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 178 (16.85%)
    24 / 165 (14.55%)
    26 / 166 (15.66%)
         number of deaths (all causes)
    0
    0
    3
         number of deaths resulting from adverse events
    0
    0
    3
    Vascular disorders
    Air embolism
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 178 (0.56%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Bronchial fistula
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Troponin I increased
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Operative haemorrhage
         subjects affected / exposed
    1 / 178 (0.56%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 178 (1.12%)
    4 / 165 (2.42%)
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical skin tear
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriospasm coronary
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 178 (0.56%)
    3 / 165 (1.82%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Low cardiac output syndrome
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    5 / 178 (2.81%)
    4 / 165 (2.42%)
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 178 (0.00%)
    2 / 165 (1.21%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal ischaemia
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic ischaemia
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 178 (1.12%)
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Compartment syndrome
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis haemophilus
         subjects affected / exposed
    0 / 178 (0.00%)
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 178 (1.12%)
    2 / 165 (1.21%)
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    2 / 178 (1.12%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 178 (0.00%)
    2 / 165 (1.21%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 178 (0.00%)
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 178 (0.56%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Xenon Including Pilot Patients Sevoflurane TIVA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    154 / 178 (86.52%)
    139 / 165 (84.24%)
    143 / 166 (86.14%)
    Investigations
    Bispectral index decreased
    Additional description: Bispectral index considered unexpectedly low for one investigator
         subjects affected / exposed
    9 / 178 (5.06%)
    0 / 165 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    9
    0
    0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    18 / 178 (10.11%)
    22 / 165 (13.33%)
    13 / 166 (7.83%)
         occurrences all number
    18
    22
    13
    Troponin T increased
         subjects affected / exposed
    9 / 178 (5.06%)
    11 / 165 (6.67%)
    15 / 166 (9.04%)
         occurrences all number
    9
    11
    15
    Troponin increased
         subjects affected / exposed
    10 / 178 (5.62%)
    13 / 165 (7.88%)
    11 / 166 (6.63%)
         occurrences all number
    10
    13
    11
    Injury, poisoning and procedural complications
    Insomnia
         subjects affected / exposed
    7 / 178 (3.93%)
    9 / 165 (5.45%)
    4 / 166 (2.41%)
         occurrences all number
    7
    9
    4
    Post procedural haemorrhage
         subjects affected / exposed
    12 / 178 (6.74%)
    12 / 165 (7.27%)
    10 / 166 (6.02%)
         occurrences all number
    12
    12
    10
    Vascular disorders
    Hypertension
         subjects affected / exposed
    39 / 178 (21.91%)
    27 / 165 (16.36%)
    37 / 166 (22.29%)
         occurrences all number
    39
    27
    37
    Hypotension
         subjects affected / exposed
    55 / 178 (30.90%)
    63 / 165 (38.18%)
    55 / 166 (33.13%)
         occurrences all number
    55
    63
    55
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    55 / 178 (30.90%)
    43 / 165 (26.06%)
    37 / 166 (22.29%)
         occurrences all number
    55
    43
    37
    Bradycardia
         subjects affected / exposed
    12 / 178 (6.74%)
    9 / 165 (5.45%)
    13 / 166 (7.83%)
         occurrences all number
    12
    9
    13
    Pericardial effusion
         subjects affected / exposed
    9 / 178 (5.06%)
    4 / 165 (2.42%)
    5 / 166 (3.01%)
         occurrences all number
    9
    4
    5
    Tachycardia
         subjects affected / exposed
    14 / 178 (7.87%)
    7 / 165 (4.24%)
    14 / 166 (8.43%)
         occurrences all number
    14
    7
    14
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    29 / 178 (16.29%)
    33 / 165 (20.00%)
    30 / 166 (18.07%)
         occurrences all number
    29
    33
    30
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    19 / 178 (10.67%)
    15 / 165 (9.09%)
    17 / 166 (10.24%)
         occurrences all number
    19
    15
    17
    Pain
         subjects affected / exposed
    15 / 178 (8.43%)
    9 / 165 (5.45%)
    16 / 166 (9.64%)
         occurrences all number
    15
    9
    16
    Pyrexia
         subjects affected / exposed
    13 / 178 (7.30%)
    20 / 165 (12.12%)
    6 / 166 (3.61%)
         occurrences all number
    13
    20
    6
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    17 / 178 (9.55%)
    15 / 165 (9.09%)
    16 / 166 (9.64%)
         occurrences all number
    17
    15
    16
    Nausea
         subjects affected / exposed
    23 / 178 (12.92%)
    19 / 165 (11.52%)
    18 / 166 (10.84%)
         occurrences all number
    23
    19
    18
    Vomiting
         subjects affected / exposed
    17 / 178 (9.55%)
    9 / 165 (5.45%)
    13 / 166 (7.83%)
         occurrences all number
    17
    9
    13
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    14 / 178 (7.87%)
    15 / 165 (9.09%)
    14 / 166 (8.43%)
         occurrences all number
    14
    15
    14
    Pleural effusion
         subjects affected / exposed
    10 / 178 (5.62%)
    8 / 165 (4.85%)
    10 / 166 (6.02%)
         occurrences all number
    10
    8
    10
    Productive cough
         subjects affected / exposed
    9 / 178 (5.06%)
    4 / 165 (2.42%)
    7 / 166 (4.22%)
         occurrences all number
    9
    4
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    9 / 178 (5.06%)
    10 / 165 (6.06%)
    6 / 166 (3.61%)
         occurrences all number
    9
    10
    6
    Renal and urinary disorders
    Oliguria
         subjects affected / exposed
    19 / 178 (10.67%)
    17 / 165 (10.30%)
    15 / 166 (9.04%)
         occurrences all number
    19
    17
    15
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    29 / 178 (16.29%)
    24 / 165 (14.55%)
    12 / 166 (7.23%)
         occurrences all number
    29
    24
    12
    Hypokalaemia
         subjects affected / exposed
    11 / 178 (6.18%)
    10 / 165 (6.06%)
    6 / 166 (3.61%)
         occurrences all number
    11
    10
    6
    Hypovolaemia
         subjects affected / exposed
    13 / 178 (7.30%)
    13 / 165 (7.88%)
    12 / 166 (7.23%)
         occurrences all number
    13
    13
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2011
    - Prolongation of inclusion period until March 2013 - Change of French coordinator
    07 Mar 2012
    - Change in an eligibility criterion relating to cardioplegia temperature. - Adjustment of the list of biomarkers to detect cardiac necrosis (Troponin and/or CK-MB) - Clarification on AEs to be reported in the clinical setting of cardiac surgery - Change of data collected to report concentrations of xenon and sevoflurane administered. - Update of anaesthetic medications to be administered in case of re-intervention - Update of evaluation of efficacy of the BIS index - Appendix 4: Update of Vaporiser and Felix Dual™ machine settings - Interval of survey of incidence of all deaths reduced from every 160 patients to every 80 patients - Change of national coordinator in Italy
    28 Feb 2013
    This amendment is dated from 28/02/2013 to 27/03/2013 according to the countries (France, Germany, Italy, The Netherlands). - Extension of the inclusion period to March 2014 - Number of sites increased to 17 sites and patients to 509

    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/28872484
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