Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin.
研究概览
简要总结
All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PA-Intravenous Sedation
Propofol based total intravenous anesthesia and postoperative sedation
干预措施: Propofol (Other)
Volatile sedation
Total inhalational anesthesia and postoperative sedation with the AnaConda device
干预措施: Isoflurane/sevoflurane (Drug)
结局指标
主要结局
The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin.
时间窗: Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU.
次要结局
- Quality of sedation(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))
- Incidence of delirium(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))
- Time to readiness for extubation, time to extubation(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))
- Length of stay within ICU, readiness for discharge from the unit(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))