Efficacy and safety of xenon anaesthesia compared to sevofluraneanaesthesia and total intravenous anaesthesia for on-pump coronaryartery bypass graft surgery: a randomised, three-arm, single-blind,international study.

• Conditions: General anesthesia for on pump coronary artery bypass surgery; MedDRA version: 16.0Level: LLTClassification code 10006894Term: CABGSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2010-020677-17-DE
• Lead Sponsor: Air Liquide Santé International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-29
• Last Update Posted: 23 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 509

Inclusion Criteria

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:
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

Exclusion Criteria

-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 aminetransferase
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