Phase 3 N=509 Randomized Single-blind Treatment

Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Coronary Artery Disease · General Anesthetic Drug Allergy · Coronary Artery Bypass Graft Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01294163 ↗

Enrolled (actual)

509

Serious AEs

15.7%

Results posted

Dec 2015

Primary outcome: Primary: Blood Level of Troponin I — 2.16; 2.57 ng/mL — p=0.02

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Xenon (Drug); Sevoflurane (Drug); Propofol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Air Liquide Santé International
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Level of Troponin I	2.16; 2.57	0.02 sig
PRIMARY Log-transformed Blood Level of Troponin I	0.30; 0.39	0.0186 sig
SECONDARY Depth of Anaesthesia	—	—
SECONDARY Arterial Oxygen Saturation	—	—
SECONDARY Haemodynamic Profile	—	—
SECONDARY Presence or Absence of Postoperative Delirium	—	—
SECONDARY Clinical Laboratory Tests	—	—
SECONDARY ECG Abnormalities	—	—
SECONDARY Vital Signs	—	—
SECONDARY Presence of Absence of Adverse Events, Including Myocardial Infarction	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01294163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.