Conditions: Elevated Cardiac Risk Coronary Arteries Disease Risk
Keywords: Xenon Cardiac safety Cardiovascular risk Non cardiac surgery Atherosclerotic vascular surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 600
Healthy volunteers: no

Brief summary:
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

Detailed description:
The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;

Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.

Arms:
arm 1: 0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A) arm 2: 0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)

Interventions: intervention 1: Xenon intervention 2: Sevoflurane
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: