Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The incidence of POCD after the surgery.
研究概览
简要总结
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elder than 60 years old
- •Speak Chinese Mandarin
- •Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery
- •The operation time is more than 2 hours.
- •Signed the informed consent
- •American Society of Anesthesiologists (ASA) classification I-II
排除标准
- •Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis
- •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- •Several audition or vision disorder
- •Patients with tumors or infections
- •Unwillingness to comply with the protocol or procedures
- •Can not communicate normally in Mandarin Chinese
- •Existing bradycardiac arrhythmia (Heart rate <60 bpm for any reasons)
- •Existing gastrointestinal ulcer
- •Existing urinary incontinence
- •Existing asthma or chronic obstructive pulmonary disease
- •Postoperative admission to ICU
- •Allergic to donepezil
研究组 & 干预措施
Control
干预措施: Placebo (Drug)
Donepezil
干预措施: Donepezil (Drug)
结局指标
主要结局
The incidence of POCD after the surgery.
时间窗: up to 7 days
次要结局
- The incidence of postoperative delirium after surgery.(1 to 7 days after surgery)
- POCD incidence one month, six months and one year after surgery.(one month, six months and one year after surgery)