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

Air Liquide

Status and phase

Completed

Phase 3

Conditions

Coronary Arteries Disease Risk

Elevated Cardiac Risk

Treatments

Drug: Xenon

Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01120405

EudraCT #2010-018703-28

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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