CARVASAXe: Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery

• Sponsor: Air Liquide Santé International (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01120405
• Collaborator: Eurofins Biomnis (Other), MONITORING FORCE GROUP CROs (Other), INFERENTIAL (Other)
• Enrollment: 600
• Locations: 13
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 46.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

Condition or Disease	Intervention/Treatment	Phase
Elevated Cardiac Risk; Coronary Arteries Disease Risk	Drug: Xenon; Drug: Sevoflurane	Phase 3

Detailed Description

The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;

Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xenon 0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)	Drug: Xenon; Other Names: LENOXe
Active Comparator: sevoflurane 0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)	Drug: Sevoflurane; Other Names: Sevo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Myocardial Necrosis (MN) [3 Postoperative Days]

   Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)

Secondary Outcome Measures

1. Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories) [3 Postoperative days]

   At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)

2. Number of Participants With Myocardial Infarction (MI) [3 Postoperative Days]

   Patients with Confirmed Myocardial Infarction (MI) by the Investigators

3. Number of Participants With Cerebro-Vascular Event [3 postoperative days]

   Patients with Cerebro-Vascular Event in the FAS

4. Number of Participants With Life-Threatening Arrhythmia [3 Postoperative Days]

   Patients with Life-Threatening Arrhythmia in the FAS

5. Number of Participants Who Died From Cardiac Origin [3 postoperative days]

   No patient died from a cardiac cause during the 3 postoperative days.

6. Number of Participants With Composite Endpoint [3 postoperative days]

   Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin

7. Systolic Blood Pressure (SBP) [From pre-induction to recovery of anesthesia]

   Repeated Systolic Blood Pressure measurements during the perioperative period

8. Vital Signs (SBP and DBP Changes) [From pre-induction to Postoperative Day 3]

   Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)

9. Vital Signs (Heart Rate Changes) [From pre-induction to Postoperative Day 3]

   Changes from baseline for Heart Rate (HR)

10. Number of Participants With Chest Pain During the 3 Postoperative Days [From Day 0 until Postoperative Day 3]

    Patients with Chest Pain reported at least once per day during the 3 Postoperative Days

11. Urine Output [From Day 0 until Postoperative Day 1]

    Urine volume in milliliter (mL) during the first postoperative hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years

• Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,

• Cardiac ischaemic risk supported by:

• History of myocardial infarction older than 1 month and/or

• Documented Stable angina (asymptomatic ± medical treatment) and/or

• History of coronary revascularisation, and/or

• Surgical Risk Index ("Lee" index) ≥ 3.

• Written informed consent

Exclusion Criteria:

• Unstable angina within the last 30 days,

• Non controlled arterial Hypertension .

• Severe Cardiac heart Failure (NYHA IV)

• Severe Chronic Obstructive Pulmonary Disease

• Patient already randomized in another ongoing clinical trial

• Patient with recent myocardial infarction (M.I) (less than one month )

• Patient already included in a clinical trial

• History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)

• Malignant hyperthermia

• Documented Elevated intracranial pressure

• Preeclampsia or eclampsia

• Pregnancy and lactation

• Presumed uncooperativeness or legal incapacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nouvel Hopital Civil	Strasbourg	Bas Rhin	France	67091
2	CHU Nord	Marseille	Bouches du Rhône	France	13915
3	Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre	Caen	Calvados	France	14033 Cedex 9
4	CHU Dijon	Dijon	Côte d'Or	France	21079
5	Hopital Pellegrin	Bordeaux	Gironde	France	33076
6	CHU Bordeaux Haut Lévèque	Bordeaux	Gironde	France	33604
7	CHU Rennes	Rennes	Ille et Vilaine	France	35009
8	CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc	Lille	Nord	France	59037 Cedex
9	CHU Clermont Ferrand	Clermont Ferrand	Puy de Dôme	France	63003
10	Hopital Henri Mondor	Creteil	Val de Marne	France	94000
11	CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577	Poitiers	Vienne	France	86021 Cedex
12	Chu Pitie Salpetriere	Paris		France	75013
13	Hopital Saint Joseph	Paris		France	75014

Sponsors and Collaborators

• Air Liquide Santé International
• Eurofins Biomnis
• MONITORING FORCE GROUP CROs
• INFERENTIAL

Investigators

• Principal Investigator: Yanncik Le Manach, MD, CHU PITIE SALPETRIERE, PARIS, FRANCE
• Study Chair: Pierre CORIAT, MD Prof, CHU PITIE SALPETRIERE, PARIS, FRANCE
• Study Chair: Benoit VALLET, MD Prof, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Air Liquide Santé International
• ClinicalTrials.gov Identifier: NCT01120405
• Other Study ID Numbers: EudraCT #2010-018703-28
• First Posted: May 11, 2010
• Last Update Posted: Jun 17, 2014
• Last Verified: May 1, 2014

• Keywords provided by Air Liquide Santé International: Xenon; Cardiac safety; Cardiovascular risk; Non cardiac surgery; Atherosclerotic vascular surgery
• Additional relevant MeSH terms: Coronary Artery Disease; Sevoflurane

Study Results

Participant Flow

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Period Title: Overall Study
STARTED	298	302
COMPLETED	271	269
NOT COMPLETED	27	33

Baseline Characteristics

Arm/Group Title	Xenon	Sevoflurane	Total
Arm/Group Description	0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)	0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)	Total of all reporting groups
Overall Participants	295	295	590
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.6 (10.3)	71.2 (10.2)	70.9 (10.2)
Sex: Female, Male (Count of Participants)
Female	57 19.3%	52 17.6%	109 18.5%
Male	238 80.7%	243 82.4%	481 81.5%
Region of Enrollment (participants) [Number]
France	295 100%	295 100%	590 100%
Participants with Baseline Cardiac Troponin (Central Laboratory) (participants) [Number]
> 99th percentile	26 8.8%	26 8.8%	52 8.8%
≤ 99th percentile	269 91.2%	269 91.2%	538 91.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Myocardial Necrosis (MN)
Description	Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)
Time Frame	3 Postoperative Days

Outcome Measure Data

Analysis Population Description

Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	273	261
Number [participants]	57 19.3%	54 18.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenon, Sevoflurane
	Comments	The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc < 10%. As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.
Statistical Test of Hypothesis	p-Value	0.0052
	Comments
	Method	Difference of proportion
	Comments
Method of Estimation	Estimation Parameter	Difference of proportion
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95%; -6.70 to 7.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
Description	At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
Time Frame	3 Postoperative days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Number [participants]	27 9.2%	25 8.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenon, Sevoflurane
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7715
	Comments
	Method	Difference of proportion
	Comments
Method of Estimation	Estimation Parameter	Difference of proportion
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; -3.90 to 5.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI)
Description	Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Time Frame	3 Postoperative Days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Number [participants]	5 1.7%	3 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenon, Sevoflurane
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4763
	Comments
	Method	Difference of proportion
	Comments
Method of Estimation	Estimation Parameter	Difference of proportion
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; -1.19 to 2.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants With Cerebro-Vascular Event
Description	Patients with Cerebro-Vascular Event in the FAS
Time Frame	3 postoperative days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Number [participants]	2 0.7%	3 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenon, Sevoflurane
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6533
	Comments
	Method	Difference of proportion
	Comments
Method of Estimation	Estimation Parameter	Difference of proportion
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -1.82 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Participants With Life-Threatening Arrhythmia
Description	Patients with Life-Threatening Arrhythmia in the FAS
Time Frame	3 Postoperative Days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Number [participants]	2 0.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenon, Sevoflurane
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1559
	Comments
	Method	Difference of proportion
	Comments
Method of Estimation	Estimation Parameter	Difference of proportion
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; -0.26 to 1.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants Who Died From Cardiac Origin
Description	No patient died from a cardiac cause during the 3 postoperative days.
Time Frame	3 postoperative days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Number [participants]	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Composite Endpoint
Description	Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
Time Frame	3 postoperative days

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Number [participants]	61 20.7%	56 19%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenon, Sevoflurane
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6056
	Comments
	Method	Difference of proportion
	Comments
Method of Estimation	Estimation Parameter	Difference of proportion
	Estimated Value	1.69
	Confidence Interval	(2-Sided) 95%; -4.74 to 8.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Systolic Blood Pressure (SBP)
Description	Repeated Systolic Blood Pressure measurements during the perioperative period
Time Frame	From pre-induction to recovery of anesthesia

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	295	295
Baseline	146.1 (21.6)	147.3 (23.6)
Minimum SBP-Induction Time	90.6 (21.3)	90.3 (20.7)
Minimum SBP-Maintenance Time	94.8 (17.8)	83.8 (14.2)
Minimum SBP- Awakening Time	123.8 (25.1)	117.6 (23.0)
Maximum SBP-Induction Time	156.0 (26.9)	153.6 (29.6)
Maximum SBP- Maintenance Time	157.8 (28.0)	144.6 (26.1)
Maximum SBP-Awakening Time	156.6 (29.1)	153.4 (27.6)

9. Secondary Outcome

Title	Vital Signs (SBP and DBP Changes)
Description	Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
Time Frame	From pre-induction to Postoperative Day 3

Outcome Measure Data

Analysis Population Description

Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	292	294
SBP-Day 1	-12.2 (25.4)	-14.2 (26.8)
SBP-Day 2	-10.8 (26.6)	-10.7 (25.6)
SBP-Day 3	-11.9 (24.7)	-12.2 (25.0)
DBP-Day 1	-6.05 (14.91)	-6.15 (15.10)
DBP- Day 2	-3.32 (14.53)	-1.46 (13.41)
DBP-Day 3	-3.73 (14.05)	-2.61 (13.90)

10. Secondary Outcome

Title	Vital Signs (Heart Rate Changes)
Description	Changes from baseline for Heart Rate (HR)
Time Frame	From pre-induction to Postoperative Day 3

Outcome Measure Data

Analysis Population Description

Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)	0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
Measure Participants	292	294
HR-Day 1	6.35 (12.03)	6.35 (12.91)
HR-Day 2	8.81 (13.64)	9.85 (12.93)
HR-Day 3	6.44 (11.72)	8.90 (14.14)

11. Secondary Outcome

Title	Number of Participants With Chest Pain During the 3 Postoperative Days
Description	Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
Time Frame	From Day 0 until Postoperative Day 3

Outcome Measure Data

Analysis Population Description

Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	292	294
Day 0	0 0%	0 0%
Day 1	0 0%	2 0.7%
Day 2	1 0.3%	2 0.7%
Day 3	2 0.7%	3 1%

12. Secondary Outcome

Title	Urine Output
Description	Urine volume in milliliter (mL) during the first postoperative hours
Time Frame	From Day 0 until Postoperative Day 1

Outcome Measure Data

Analysis Population Description

Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Arm/Group Title	Xenon	Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
Measure Participants	292	294
Mean (Standard Deviation) [mL]	1279.0 (723.1)	1324.4 (631.8)

Adverse Events

Time Frame	Adverse Events observed after the start of study drug administration and during postoperative 3-day period
Adverse Event Reporting Description	Participants at risks are the patients from the Treated Set, ie randomised patients who received the study medication.
Arm/Group Title	Xenon		Sevoflurane
Arm/Group Description	0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)		0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
All Cause Mortality
	Xenon		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Xenon		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/292 (5.8%)		17/294 (5.8%)
Cardiac disorders
Myocardial Infarction	3/292 (1%)		3/294 (1%)
Cardio-respiratory arrest	0/292 (0%)		2/294 (0.7%)
Acute Coronary Syndrome	1/292 (0.3%)		0/294 (0%)
Acute Myocardial Infarction	1/292 (0.3%)		0/294 (0%)
Arrhythmia supraventricular	0/292 (0%)		1/294 (0.3%)
Atrial Fibrillation	1/292 (0.3%)		0/294 (0%)
Bradyarrhythmia	0/292 (0%)		1/294 (0.3%)
Subendocardial ischemia	0/292 (0%)		1/294 (0.3%)
Hepatobiliary disorders
Gallblader Necrosis	0/292 (0%)		1/294 (0.3%)
Injury, poisoning and procedural complications
Post Procedural Haemorrhage	2/292 (0.7%)		3/294 (1%)
Post Procedural Haematoma	2/292 (0.7%)		2/294 (0.7%)
Procedural Hypotension	1/292 (0.3%)		1/294 (0.3%)
Graft thrombosis	1/292 (0.3%)		0/294 (0%)
Operative Haemorrhage	1/292 (0.3%)		0/294 (0%)
Shunt Trombosis	1/292 (0.3%)		0/294 (0%)
Wound	1/292 (0.3%)		0/294 (0%)
Investigations
Troponin Increased	1/292 (0.3%)		2/294 (0.7%)
Metabolism and nutrition disorders
Diabetic Ketoacidosis	1/292 (0.3%)		0/294 (0%)
Nervous system disorders
Ischaemic Stroke	0/292 (0%)		2/294 (0.7%)
Agitation	1/292 (0.3%)		0/294 (0%)
Cerebrovascular Accident	1/292 (0.3%)		0/294 (0%)
Confusional State	1/292 (0.3%)		0/294 (0%)
Loss of Consciousness	0/292 (0%)		1/294 (0.3%)
Transient Ischaemic Attack	0/292 (0%)		1/294 (0.3%)
Psychiatric disorders
Aggression	1/292 (0.3%)		0/294 (0%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	0/292 (0%)		3/294 (1%)
Vascular disorders
Peripheral Ischaemia	2/292 (0.7%)		1/294 (0.3%)
Hypertension	0/292 (0%)		1/294 (0.3%)
Other (Not Including Serious) Adverse Events
	Xenon		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/292 (27.1%)		84/294 (28.6%)
General disorders
Hyperthermia	13/292 (4.5%)		17/294 (5.8%)
Pain	8/292 (2.7%)		15/294 (5.1%)
Injury, poisoning and procedural complications
Procedural Pain	21/292 (7.2%)		23/294 (7.8%)
Procedural Hypertension	24/292 (8.2%)		14/294 (4.8%)
Procedural Nausea	21/292 (7.2%)		12/294 (4.1%)
Procedural Vomiting	16/292 (5.5%)		10/294 (3.4%)
Vascular disorders
Hypertension	17/292 (5.8%)		20/294 (6.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Air Liquide Sante International may delay publication or disclosure for a term not exceeding eighteen (18) months with effect from the request in the event that Air Liquide Sante International wishes to seek protection of the results of the Trial by industrial property rights.