Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of delirium 3 days after the end of operation
研究概览
简要总结
Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elderly patients undergoing hip or knee arthroplasty under general anesthesia.
- •body mass index >30 kg/m2
排除标准
- •moderate to severe liver dysfunction
- •moderate to severe renal dysfunction
- •unable to extubate in the operation room after operation
- •benzodiazepine dependence
- •sensitivity to anesthetic drugs used for study (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Sugammadex, Flumazenil)
- •acute angle glaucoma
- •received (benzodiazepine, antianxiety drugs, antidepressant, antipsychotic drugs) within 24 hours.
- •acute psychotic depression
- •history stroke or cerebrovascular disease
研究组 & 干预措施
Remimazolam group
Remimazolam is started during induction of anesthesia at the rate of 6 mg/kg/hr and continued at the rate of 1 mg/kg/hr (within 0.3-2 mg/kg/hr). Remimazolam is stopped 20 minutes before end of operation.
干预措施: Remimazolam (Byfavo) (Drug)
Propofol group
Propofol is continuously infused within 1-5 μg/mL.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of delirium 3 days after the end of operation
时间窗: Upto 3 days after surgery
delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination
次要结局
- quality of recovery (QoR-15) 3 days after the end of the operation(Upto 3 days after surgery)
研究者
In-Jung Jun
assisstant professor
Inje University