Coronary Artery Disease Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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