Efficacy and Safety of Xenon Anaesthesia Compared to Sevoflurane Anaesthesia and Total Intravenous Anaesthesia for On-pump Coronary Artery Bypass Graft Surgery: a Randomised, Three-arm, Single-blind, International Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 509
- Locations
- 31
- Primary Endpoint
- Blood Level of Troponin I
Study Overview
Brief Summary
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.
This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.
The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
Detailed Description
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.
This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.
The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •coronary artery disease
- •elective surgery, planned coronary artery bypass graft
- •moderate hypothermia or normothermia
- •cardiac arrest cold and warm cardioplegia
- •normal of moderately impaired left ventricular systolic function
- •written informed consent
Exclusion Criteria
- •pregnancy or child bearing potential
- •ongoing treatment with nicorandil or sulfonylurea medication
- •severe renal or hepatic dysfunction
- •ongoing myocardial infarction or unstable angina
Arms & Interventions
Xenon
Intervention: Xenon (Drug)
Sevoflurane
Intervention: Sevoflurane (Drug)
Total intravenous anaesthesia
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Blood Level of Troponin I
Time Frame: Sampling performed 24 hours after the end of the surgical procedure
Blood level of troponin I measured by a central laboratory
Log-transformed Blood Level of Troponin I
Time Frame: Sampling performed 24 hours after the end of the surgical procedure
Blood level of troponin I measured by a central laboratory
Secondary Outcomes
- Depth of Anaesthesia(4 hours)
- Arterial Oxygen Saturation(4 hours)
- Haemodynamic Profile(4 hours)
- Presence or Absence of Postoperative Delirium(7 days)
- Clinical Laboratory Tests(7 days)
- ECG Abnormalities(7 days)
- Vital Signs(7 days)
- Presence of Absence of Adverse Events, Including Myocardial Infarction(7 days)