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

Air Liquide

Status and phase: Completed; Phase 3

Conditions: General Anesthetic Drug Allergy; Coronary Artery Bypass Graft Surgery; Coronary Artery Disease

Treatments: Drug: Xenon; Drug: Sevoflurane; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294163

ALMED-09-C3-026

Details and patient eligibility

About

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.

Enrollment: 509 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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509 participants in 3 patient groups

Xenon

Experimental group

Treatment:

Drug: Xenon

Sevoflurane

Active Comparator group

Treatment:

Drug: Sevoflurane

Total intravenous anaesthesia

Active Comparator group

Treatment:

Drug: Propofol