Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Number of patients with postoperative cognitive dysfunction (POCD)
研究概览
简要总结
As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.
详细描述
The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who receive cardiac valvular surgery
- •18 to 65 years
- •American society of anesthesiologists classification Ⅱto Ⅲ
- •education level higher than elementary school
排除标准
- •Patients are not expected to be alive for longer than 3 months.
- •Mini-mental State Examination (MMSE) score ≤
- •current use of sedatives or antidepressant
- •history of dementia, psychiatric illness or any diseases of central nervous system.
- •accompanying liver or kidney function deficiency
- •history of some endocrine disease
- •alcoholism and drug dependence
- •patients previously included in this study or currently included in the other clinical study
- •patients who have second surgery during the study period
- •difficult to follow up or patients with poor compliance
研究组 & 干预措施
Sevoflurane
Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.
干预措施: sevoflurane (Drug)
Propofol
Maintenance of anesthesia propofol during the cardiac valvular surgery.
干预措施: propofol (Drug)
结局指标
主要结局
Number of patients with postoperative cognitive dysfunction (POCD)
时间窗: From 7 days after the surgery to the day of discharge from hospital
POCD is a composite outcome measure
次要结局
- Postoperative delirium (POD)(Up to 7 days after the surgery)
研究者
Hong Li
Director, Department of Anesthesiology
Xinqiao Hospital of Chongqing