EUCTR2010-020677-17-DE进行中（未招募）不适用
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. - Xenon in Cardiac Surgery
Air Liquide Santé International0 个研究点目标入组 509 人开始时间: 2011年6月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 509
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •-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
研究者
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