NCT05242419招募中不适用
A Multi-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of delirium within 7 days after operation
研究概览
简要总结
To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac 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, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 75 years old.
- •Comply with the indication of non-cardiac surgery under general anesthesia.
- •Anesthesia grade of American Society of Anesthesiologist (ASA) as III~IV grade.
- •The estimated operation time ≥ 2 hours.
- •Voluntarily sign the informed consent form.
排除标准
- •Patients with impaired renal function (Cr is 1.5 times higher than the upper limit of the normal value of the central laboratory) or abnormal liver function (Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) are 2 times higher than the upper limit of the normal value of the central laboratory).
- •Patients who are positive for infectious diseases.
- •Patients accompanied with central nervous system injury.
- •Patients with previous history of delirium and epilepsy, long-term use of psychoactive drugs or preoperative assessment of delirium.
- •Patients who involved diseases with drug taboos, bronchial asthma, mechanical intestinal obstruction and urinary tract obstruction, or serious systemic diseases, especially circulatory diseases: such as myocardial infarction, heart failure, angina pectoris, history of sinus bradycardia.
- •Patients who are known to be allergic to narcotic drugs or Huperzine A Injection, or must use drugs that are not compatible with Huperzine An Injection.
- •patients who participated in other clinical trials within 3 months before this study, for any reason, who could not tolerate the test or cooperate with the examination, or who has any aphasia, audio-visual dysfunction, etc.
- •the investigators think that the patients is not suitable to participate in this study.
研究组 & 干预措施
Treatment group
Experimental
Huperzine A Injection
干预措施: Huperzine A Injection (Drug)
Control group
Placebo Comparator
0.9% Sodium Chloride Injection
干预措施: Sodium Chloride 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
Delirium will be evaluated by The 3-dimensional Confusion Assessment Method(3D-CAM) and delirium rating scale-revised-98(DRS-R-98) scale form.
次要结局
- type of delirium(evaluated at screening, 24 hours, 48 hours, 72 hours after operation)
- severity of delirium(evaluated at screening, 24 hours, 48 hours, 72 hours after operation)
- duration of delirium(evaluated at screening, 24 hours, 48 hours, 72 hours after operation)
- length of hospital stay(from the day of operation to the day of discharge, around 7 to 14 days)
- Economic indicators (total hospitalization cost, anesthesia cost, operation cost).(through study completion, up to 2 months)
- Occurrence of complications(through study completion, up to 2 months)
- the total score of Mini-mental State Examination scale(evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge)
- the score of EuroQol (EQ-5D) scale(96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge)
- Incidence of Mortality(the day of hospital discharge, and the day of follow-up, around 30 days after discharge)
研究者
Ting Li
Principal Investigator
Second Affiliated Hospital of Wenzhou Medical University
研究点 (1)
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