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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Liquide Santé International
• Collaborators: BIOMNIS Central laboratory; Eurofins Biomnis; INFERENTIAL; MONITORING FORCE GROUP CROs
• Treatments: Sevoflurane; Xenon

Criteria

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