NCT01948765已完成2 期
Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- intraoperative haemodynamic stability
研究概览
简要总结
The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease scheduled for elective OPCAB-surgery
- •patients willing and able to complete the requirements of this study
- •Ejection fraction >30%
排除标准
- •Lack of informed consent
- •age < 18 years
- •COPD GOLD >II
- •Renal dysfunction defined as serum-creatinine >1.5mg/dl
- •acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
- •single vessel grafting
- •disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression, low preoperative cognitive state (MMSE at baseline <25), history of stroke with residuals, increased intracranial pressure
- •Hypersensitivity to the study medication
- •Presumed uncooperativeness or legal incapacity
研究组 & 干预措施
Xenon and propofol
Active Comparator
干预措施: Xenon and propofol (Drug)
propofol
Placebo Comparator
干预措施: propofol (Drug)
结局指标
主要结局
intraoperative haemodynamic stability
时间窗: intra-operative
Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption
次要结局
- MACCE (major adverse cardiac and cerebral events)(up to six months postoperative)
- cerebrovascular accident not included in MACCE(up to six months postoperative)
- postoperative renal function(up to five days postoperative)
- requirement for blood(product) transfusion(up to five days postoperative)
- length of stay(participants will be followed for the duration of hospital stay, an expected average of 10 days.)
- severity of postoperative critical illness(up to five days postoperative)
- incidence and duration of postoperative delirium(participants will be followed for the duration of hospital stay, an expectged average of 10 days)
- incidence of further AE, SAE and SUSAR(participants will be followed for the duration of hospital stay, an expected average of 10 days)
研究者
prof Dr Steffen Rex
PhD, MD
Universitaire Ziekenhuizen KU Leuven
研究点 (1)
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