Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
研究概览
简要总结
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years old and ≤ 85 years old;
- •Selective non-cardiac major surgery;
- •Informed consent and voluntary participation in the trial;
- •ASA class I-II;
- •Anticipated operation duration ≥ 2 hours;
- •No plan to ICU after operation.
排除标准
- •Neurosurgery;
- •Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
- •Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
- •Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
- •Allergic or contraindications to droperidol or fentanyl citrate;
- •Admitted to ICU after operation.
- •Operation duration < 2 hours;
研究组 & 干预措施
Neuroleptanalgesia group
Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.
干预措施: low-dose neuroleptanalgesia (Drug)
Control group
The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
时间窗: Up to 7 days after surgery（or leaving hospital）
次要结局
- Incidence of major serious complications and serious arrhythmia(Up to 7 days after surgery（or leaving hospital）)
- Duration of postoperative delirium(Up to 7 days after surgery（or leaving hospital）)
- Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Incidence of postoperative nausea and vomiting(Up to 7 days after surgery（or leaving hospital）)
- Incidence of postoperative hypoxia(Up to 1 day after surgery)
- Patients' satisfaction(Up to 7 days after surgery（or leaving hospital）)