NCT05401058终止不适用
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 797
- 试验地点
- 9
- 主要终点
- Incidence of delirium within 7 days after operation
研究概览
简要总结
The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.
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 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥65 years
- •American Society of Anesthesiologists (ASA): I-III
- •Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery
- •Estimated operation time more than 2 hours
- •Not expected to be admitted to ICU postoperatively
- •Proficient in Chinese
- •Informed consent
排除标准
- •Morbid obesity with BMI >35 kg/m2;
- •History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc;
- •Corrected QT (QTc) of electrocardiogram> 500ms;
- •Preoperative liver insufficiency (Child Pugh grade C);
- •End-stage renal disease requiring dialysis;
- •Severe heart failure [Metablic equivalent (METs)<4];
- •Allergic to droperidol;
- •Inability to communicate due to coma or dementia in preoperative period;
- •Preoperative delirium, assessed by 3D-CAM;
- •More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits);
- •Participating in conflicting clinical trials;
- •Expected to have an additional operation within 7 days after the index operation.
研究组 & 干预措施
Placebo group
Placebo Comparator
Normal saline 0.5ml
干预措施: Saline (Drug)
Experimental group
Experimental
Droperidol 1.25mg/0.5ml
干预措施: Droperidol Injection (Drug)
结局指标
主要结局
Incidence of delirium within 7 days after operation
时间窗: 7 days after operation
Incidence of delirium within 7 days after operation
次要结局
- Postoperative hospital duration(From end of operation to discharge, an average of 1 week)
- Severity of delirium(From the end of operation to 7 days after opertation)
- Delirium-free days(From the end of operation to 7 days after opertation)
- cognitive function at 30 days and 6 months(30 days and 6 months after surgery)
研究者
研究点 (9)
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