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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Liquide Santé International
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Anesthetics; Propofol; Sevoflurane; Xenon

Criteria

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