Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 684
- 试验地点
- 1
- 主要终点
- Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
研究概览
简要总结
Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Most patients will receive general anesthesia during surgery. Two groups of general anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not different in patients received intravenous anesthetics only or sevoflurane (a volatile anesthetic-based general anesthesia) for their major intra-abdominal surgery.
详细描述
Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) sevoflurane-based general anesthesia group, and 2) propofol-based general anesthesia group. Each group will need 221 patients to detect 1/3 of decrease or increase in the rate of POCD of one group compared with another group at about one week after surgery, assuming the overall rate of POCD at this time is about 40% at this time. Considering about 10% loss to follow-up, we will have 250 patients in each group. In addition, investigators will need 184 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are ≥ 60 years old.
- •the surgery is laparoscopic surgery and is expected to last for ≥ 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery.
- •lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.
排除标准
- •Patients are not expected to be alive for longer than 3 months.
- •Mini-mental State Examination (MMSE) [18] score ≤
- •history of dementia, psychiatric illness or any diseases of central nervous system.
- •current use of sedatives or antidepressant.
- •alcoholism and drug dependence.
- •patients previously included in this study (for patients who have second intra-abdominal surgery during the study period).
- •difficult to follow up or patients with poor compliance.
- •uncontrolled hypertension (> 180/100 mmHg)
研究组 & 干预措施
Sevoflurane & remifentanil
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
干预措施: Sevoflurane (Drug)
Sevoflurane & remifentanil
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
干预措施: remifentanil (Drug)
propofol & remifentanil
propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)
干预措施: propofol (Drug)
propofol & remifentanil
propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)
干预措施: remifentanil (Drug)
结局指标
主要结局
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
时间窗: At 7 days after the surgery
Incidence of POCD in patients will be determined by a set of cognitive tests.
次要结局
- Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)(At 3 months after the surgery)
研究者
Zhiyi Zuo
Visiting Professor
Sun Yat-sen University