Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Tracking Information
First Submitted Date ICMJE	February 9, 2011
First Posted Date ICMJE	February 11, 2011
Results First Submitted Date	November 6, 2015
Results First Posted Date	December 21, 2015
Last Update Posted Date	December 21, 2015
Study Start Date ICMJE	April 2011
Actual Primary Completion Date	April 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 18, 2015)	Blood Level of Troponin I [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]Blood level of troponin I measured by a central laboratory; Log-transformed Blood Level of Troponin I [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]Blood level of troponin I measured by a central laboratory
Original Primary Outcome Measures ICMJE; (submitted: February 10, 2011)	Blood Level of Troponin I [ Time Frame: 1 day ]; Troponin I, sampling perfomed 24 hours after the end of the surgical procedure and measured by a central laboratory.
Change History	Complete list of historical versions of study NCT01294163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 10, 2011)	Depth of Anaesthesia [ Time Frame: 4 hours ]On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor); Arterial Oxygen Saturation [ Time Frame: 4 hours ]Arterial blood gases; Haemodynamic Profile [ Time Frame: 4 hours ]Monitoring of heart rate, arterial blood pressure, central venous pressure.; Presence or Absence of Postoperative Delirium [ Time Frame: 7 days ]Confusion Assessment Method; Clinical Laboratory Tests [ Time Frame: 7 days ]; ECG Abnormalities [ Time Frame: 7 days ]; Vital Signs [ Time Frame: 7 days ]; Presence of Absence of Adverse Events, Including Myocardial Infarction [ Time Frame: 7 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
Official Title ICMJE	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
Brief Summary	Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction. This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients. The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Coronary Artery Disease; General Anesthetic Drug Allergy; Coronary Artery Bypass Graft Surgery
Intervention ICMJE	Drug: Xenon Inhaled xenon, maximal inspired concentration of 65%.; Drug: Sevoflurane Inhaled sevoflurane, maximal inspired concentration of 1.8%.; Drug: Propofol Hourly dose of 2-4 mg/kg
Study Arms	Experimental: Xenon Intervention: Drug: Xenon; Active Comparator: Sevoflurane Intervention: Drug: Sevoflurane; Active Comparator: Total intravenous anaesthesia Intervention: Drug: Propofol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 22, 2014)	509
Original Estimated Enrollment ICMJE; (submitted: February 10, 2011)	492
Actual Study Completion Date	April 2014
Actual Primary Completion Date	April 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: coronary artery disease; elective surgery, planned coronary artery bypass graft; moderate hypothermia or normothermia; cardiac arrest cold and warm cardioplegia; normal of moderately impaired left ventricular systolic function; written informed consent Exclusion Criteria: pregnancy or child bearing potential; ongoing treatment with nicorandil or sulfonylurea medication; severe renal or hepatic dysfunction; ongoing myocardial infarction or unstable angina
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France, Germany, Italy, Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01294163
Other Study ID Numbers ICMJE	ALMED-09-C3-026
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Air Liquide Santé International
Study Sponsor ICMJE	Air Liquide Santé International
Collaborators ICMJE	Orion Corporation, Orion Pharma
Investigators ICMJE	Principal Investigator: Jan HOFLAND, MD, PhD Thorax Centre Erasmus MC, Rotterdam, the Netherlands
PRS Account	Air Liquide Santé International
Verification Date	December 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP