A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative cognitive dysfunction
研究概览
简要总结
The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction
详细描述
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.
Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent given
- •Scheduled to undergo elective non-cardiac surgeries under general anesthesia
- •ASA Physical Score I-III
排除标准
- •Patients with a history of neurological disease, such as Alzheimer disease.
- •Patients with a history of psychiatric disease
- •Patients with a medication history of antipsychotic drugs.
- •Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
- •Patients with preoperative delirium.
- •Patients who have severe adverse events, such as cardiac arrest.
- •Patients who preoperative MMSE score are below 20;
- •Patients who undergo second operation in a short period.
研究组 & 干预措施
Desflurane
Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.
干预措施: Desflurane (Drug)
Propofol
Patients allocated to this arm will receive propofol during the maintenance of anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of postoperative cognitive dysfunction
时间窗: on the 30th day after surgery
Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery
次要结局
- Neural and hemodynamic responses during desflurane general anesthesia(5 minutes before anesthesia introduction to 5 minutes after emergence)
- Length of Hospital stay(From the date of admission until discharged from hospital, within 30 days)
- Adverse events(Within 30 days after surgery)
- Incidence of postoperative nausea and vomiting(Within 7 days after surgery)
- EEG frequency spectrum(5 minutes before anesthesia introduction to 5 minutes before discharge from PACU)
- Incidence of postoperative delirium(1-7days after surgery, on the 30th day after surgery)
- Mortality(Within 30 days after surgery)
- Hospital readmission(Within 30 days after surgery)
- Postoperative Pain(Within 3 days after surgery)
研究者
Anshi Wu
Head of Anesthesiology
Beijing Chao Yang Hospital