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.
- Conditions
- General anesthesia for on pump coronary artery bypass surgeryMedDRA version: 14.1Level: LLTClassification code 10006894Term: CABGSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2010-020677-17-NL
- Lead Sponsor
- Air Liquide Santé International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 508
1)Male or female patients aged 18 years (or having reached majority if the legal age of majority is over 18) or more at the date of selection
2)Coronary heart disease requiring elective isolated coronary artery bypass graft surgery to be performed with cardiopulmonary bypass in mild hypothermia (central temperature between 32° and 34° Celsius) or normothermia with cardiac arrest and cold or warm cardioplegia
3)Normal or moderately impaired left ventricular systolic function (corresponding to a left ventricular ejection fraction above or equal to 35%, if available)
4)Written informed consent signed and dated by the patient after full explanation of the study has been given by the investigator prior to participation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 412
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96
-Legal incapacity or limited legal capacity
- Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
- Patient previously randomised in this study
- Recent acute myocardial infarction (within 7 days)
- Ongoing unstable angina
- Active endocarditis
- Ongoing treatment with nicorandil
- Ongoing treatment with a sulfonylurea medication if this treatment cannot be replaced 24 hours before surgery
- Participation in a drug or device trial within the previous 30 days
- Known contraindication to xenon, sevoflurane, propofol or sufentanil
- Recent or ongoing myocardial damage/infraction with cardiac troponin level assessed within 24 hours of surgery above the upper reference limite for the diagnosis of mycocardial infraction (local laboratory) or prolonged thoracic pain and ST-segement deviation at rest
- Severe renal dysfunction with preoperative value of serum creatinine level above 200 micromoles/litre(local laboratory)
- Severe haptic dysfunction with preoperative value of alanine amine-transferase or alkaline phosphatase three times above the upper normal value(loval laboratory)
- Severely depressed left ventricular function, corresponding to an ejection fraction below 35%,if available
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method