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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
509
Inhaled xenon, maximal inspired concentration of 65%.
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
Hourly dose of 2-4 mg/kg
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron, France
CHU de Caen
Caen, France
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
Nantes, France
Centre Hospitalo-Universitaire Pitié-Salpetrière
Paris, France
Hôpital du Haut-Lévêque
Pessac, France
Hôpital Pontchaillou
Rennes, France
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Centre Hospitalier de Rangueil
Toulouse, France
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
University Hospital Aachen
Aachen, Germany
...and 7 more locations
Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Time frame: Sampling performed 24 hours after the end of the surgical procedure
Log-transformed Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Time frame: Sampling performed 24 hours after the end of the surgical procedure
Depth of Anaesthesia
On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
Time frame: 4 hours
Arterial Oxygen Saturation
Arterial blood gases
Time frame: 4 hours
Haemodynamic Profile
Monitoring of heart rate, arterial blood pressure, central venous pressure.
Time frame: 4 hours
Presence or Absence of Postoperative Delirium
Confusion Assessment Method
Time frame: 7 days
Clinical Laboratory Tests
Time frame: 7 days
ECG Abnormalities
Time frame: 7 days
Vital Signs
Time frame: 7 days
Presence of Absence of Adverse Events, Including Myocardial Infarction
Time frame: 7 days
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