Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery

Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study

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.

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.

Inclusion Criteria:

• Age ≥ 18 years

• Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,

• Cardiac ischaemic risk supported by:

  • History of myocardial infarction older than 1 month and/or
  • Documented Stable angina (asymptomatic ± medical treatment) and/or
  • History of coronary revascularisation, and/or
  • Surgical Risk Index ("Lee" index) ≥ 3.
  • Written informed consent

Exclusion Criteria:

• Unstable angina within the last 30 days,
• Non controlled arterial Hypertension .
• Severe Cardiac heart Failure (NYHA IV)
• Severe Chronic Obstructive Pulmonary Disease
• Patient already randomized in another ongoing clinical trial
• Patient with recent myocardial infarction (M.I) (less than one month )
• Patient already included in a clinical trial
• History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)
• Malignant hyperthermia
• Documented Elevated intracranial pressure
• Preeclampsia or eclampsia
• Pregnancy and lactation
• Presumed uncooperativeness or legal incapacity