NCT01294163

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• General Anesthetic Drug Allergy
• Coronary Artery Bypass Graft Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-02-11
• Last updated: 2015-12-21
• Results posted: 2015-12-21

Locations

17 sites across 4 countries: France, Germany, Italy, Netherlands