Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients
概览
- 阶段
- 不适用
- 干预措施
- remimazolam
- 疾病 / 适应症
- General Anesthetic Drug Adverse Reaction
- 发起方
- Zhihong LU
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- incidence of delirium by 3 days after surgery
- 状态
- 已完成
- 最后更新
- 2个月前
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.
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China
入排标准
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
研究组 & 干预措施
remimazolam
remimazolam continuous infusion is used for general anesthesia; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery
干预措施: remimazolam
propofol
propofol continuous infusion is used for general anesthesia; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery
干预措施: propofol
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
- incidence of hypotension during surgery(from start of anesthesia induction to extubation, in an average of 2 hours)
- incidence of delirium by 30 minutes after extubation(from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes)
- incidence of delirium by 1 day after surgery(from end of surgery to 1 day after surgery, in a total of 1 day)
- incidence of hypertension during surgery(from start of anesthesia induction to extubation, in an average of 2 hours)
- time to awake(from end of surgery to response to verbal command, in an average of 10 minutes)
- Duration of sleep on the first night after surgery(from end of surgery to 24 hours after surgery, in a total of 24 hours)