Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- incidence of delirium by 3 days after surgery
研究概览
简要总结
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium 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
- Treatment
- 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
- •Age ≥60 years
- •patients scheduled for elective surgery under general anesthesia
排除标准
- •American Society of Anesthesiologists status ≥Ⅳ
- •history of neurologic or psychiatric diseases
- •difficulty in communication
- •abuse of drug or alcohol
- •suspected allergy to propofol or benzodiazepines
- •significant cardiac, pulmonary, hepatic, or renal dysfunction
研究组 & 干预措施
propofol
Propofol (1.5 mg/kg) is used for anesthesia induction. Propofol continuous infusion is used for general anesthesia maintenance; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery
干预措施: propofol (Drug)
remimazolam
Remimazolam (0.15 mg/kg) is used for anesthesia induction. Remimazolam continuous infusion is used for general anesthesia maintenance; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery
干预措施: remimazolam (Drug)
结局指标
主要结局
incidence of delirium by 3 days after surgery
时间窗: from end of surgery to 3 days after surgery, in a total of 3 days
次要结局
- dosage of vasoactive drugs during surgery(from start of anesthesia induction to extubation, in an average of 2 hours)
- incidence of delirium by 30 minutes after extubation (emergence delirium)(from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes)
- time to eye opening(from end of surgery to open eye response to verbal command, in an average of 10 minutes)
- time to orientation(from end of surgery to being able to speak out name in an average of 10 minutes)
- the visual analogue scale of sleep on the next day after surgery(from end of surgery to 24 hours after surgery, in a total of 24 hours)
- the Athens Insomnia scale (AIS) of sleep on the next day after surgery(from end of surgery to 24 hours after surgery, in a total of 24 hours)
- the time to onset of delirium(from end of surgery to onset of delirium, in an average of 1 days)
- the duration of delirium(from onset of delirium to the last day of delirium, in an average of 3 days)
- incidence of hypotension during surgery(from start of anesthesia induction to extubation, in an average of 2 hours)
- incidence of delirium by 1 day after surgery(from end of surgery to 1 day after surgery, in a total of 1 day)
- Duration of sleep on the first night after surgery(from end of surgery to 24 hours after surgery, in a total of 24 hours)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China