Title
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
Phase
Phase 3Lead Sponsor
Air LiquideStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Elevated Cardiac Risk Coronary Arteries Disease RiskIntervention/Treatment
sevoflurane xenon xe-133 ...Study Participants
600The 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.
0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
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
| Event Type | Organ System | Event Term | Xenon | Sevoflurane |
|---|
Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)
At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Patients with Cerebro-Vascular Event in the FAS
Patients with Life-Threatening Arrhythmia in the FAS
Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
Repeated Systolic Blood Pressure measurements during the perioperative period
Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
Changes from baseline for Heart Rate (HR)
Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
No patient died from a cardiac cause during the 3 postoperative days.
Urine volume in milliliter (mL) during the first postoperative hours