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

NCT01294163

CompletedPhase 3

Sponsor: Air Liquide Santé International

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

Interventions: Xenon, Sevoflurane, Propofol

Countries: France, Germany, Italy, Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (17)
  • Bron, France
  • Caen, France
  • Nantes, France
  • Paris, France
  • Pessac, France
  • Rennes, France
  • Strasbourg, France
  • Toulouse, France
  • Kiel, Schleswig-Holstein, Germany
  • Aachen, Germany
  • Bremen, Germany
  • Frankfurt, Germany
  • Lübeck, Germany
  • Rostock, Germany
  • Rome, Italy
  • Amsterdam, Netherlands
  • Rotterdam, Netherlands