Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- delirium
研究概览
简要总结
Investigators investigates the effect of perioperative dexmedetomidine 0.5 ug/kg/hr followed by a postoperative continuous infusion fentanyl-based PCA(Patient-Controlled Analgesia) drug mixed with dexmedetomidine 0.2ug/kg/hr for two days on reducing postoperative delirium and postoperative rescue analgesics in elderly patients who undergo hip surgery. The other half of patients received fentanyl-based PCA only.
详细描述
Elderly patients are susceptible to postoperative delirium. Delirium occurs in 10~60% and is associated with longer hospital stays, increased costs, and morbidity. Postoperative delirium usually occurs 2~3 days after surgery. Intraoperative infusion of dexmedetomidine lacks preventing postoperative delirium in elderly noncardiac major surgery.
We hypothesized postoperative dexmedetomidine for two days as a mixture drug of fentanyl-based PCA could reduce the incidence of postoperative delirium. We compared this effect with other control group who received fentanyl-based PCA only.
We also investigate EEG patterns of patients during emergence and compared the EEG patterns who developed delirium postoperatively in PACU(Postanesthesia care unit) or general ward. Dexmedetomidine has analgesic effect. We expected postoperative dexmedetomidine has benefits of opioid sparing effects.
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
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III
排除标准
- •history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy
研究组 & 干预措施
dexmedetomidine group
dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
干预措施: Dexmedetomidine (Drug)
dexmedetomidine group
dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
干预措施: Fentanyl-based PCA infusion (Drug)
control group
Fentanyl-based PCA infusion for 2 days
干预措施: Fentanyl-based PCA infusion (Drug)
结局指标
主要结局
delirium
时间窗: 2 days
reduction of incidence of delirium
次要结局
未报告次要终点
研究者
Il Ok Lee
professor
Korea University Guro Hospital