Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay
研究概览
简要总结
Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.
The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.
详细描述
Background
It is commonly believed that the choice of the primary anesthetic agent does not result in different outcomes after cardiac surgery. Recent evidence however has indicated that volatile anesthetics improve post-ischemic recovery. These results have been summarized in a meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile anesthetics was associated with significant reductions of myocardial infarctions (24/979 [2.4%] in the volatile anesthetics group vs 45/874 [5.1%] in the control arm, odds ratio [OR]=0.51 [0.32-0.84], and mortality (4/977 [0.4%] vs 14/872 [1.6%], OR=0.31 [0.12-0.80].
Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit stay (WMD=-7.10 hours [-11.47; -2.73], and time to hospital discharge (WMD=-2.26 days [-3.83; -0.68].
All the studies of the meta-analysis included low risk patients undergoing isolated procedures (mostly coronary artery bypass grafting).
Objectives
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •written informed consent
- •scheduled procedures
排除标准
- •ongoing acute myocardial infarction
- •cardiac troponin >1 ng/ml
- •previous unusual response to an anesthetic
- •use of sulfonylurea, theophylline or allopurinol
- •thoracotomy
研究组 & 干预措施
sevoflurane
The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).
干预措施: sevoflurane (Drug)
propofol
The control group will receive propofol for the same 4-6 hours period.
干预措施: propofol (Drug)
结局指标
主要结局
Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay
次要结局
- cardiac troponin release
- incidence of perioperative myocardial infarction
- time on mechanical ventilation
- postoperative hospital stay
研究者
Giovanni Landoni
DM
Università Vita-Salute San Raffaele