The Incidence of Postoperative Delirium According to the Different Intraoperative Sedatives, Dexmedetomidine vs. Propofol, in Elderly Patients Undergoing Orthopedic Lower Limb Surgery With Spinal Anesthesia: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 748
- 试验地点
- 1
- 主要终点
- Postoperative delirium
研究概览
简要总结
Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive, and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is important to promptly manage such behaviors associated with hyperactive delirium. Intraoperative sedation plays an important role in relieving anxiety or stress response of patients. Propofol-a common sedative agent-was reported to cause delirium more frequently, compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU sedation or procedural sedation. However, there has not been any prospective randomized study investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study, based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence of abnormal psycho-motor behavior compared with propofol sedation, investigators prospectively will investigate the incidence of postoperative delirium in elderly patients who undergo orthopedic surgery with regional anesthesia.
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
- 65 Years 至 90 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo orthopedic surgery under spinal anesthesia
- •Patients who want to sedation during the surgery
- •Age of 65 years or greater
- •American Society of Anesthesiologists physical status classification 1 and 2
排除标准
- •General anesthesia
- •Age < 65 years
- •Patients who do not want to sedation during the surgery
- •Patients who do not receive patient controlled analgesia postoperatively.
- •Cognitive disorders
- •Central nervous system disease, including dementia and Parkinson's disease
研究组 & 干预措施
PPF
Patient who received propofol during the operation
干预措施: Propofol (Drug)
DEX
Patient who received dexmedetomidine during the operation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative delirium
时间窗: Within 3 day postoperatively
The incidence of postoperative delirium
次要结局
- Numerical rating scale(Postoperative 72 hour)
- Patient controlled analgesia (PCA)(Postoperative 72 hour)
- Rescue analgesics(Postoperative 72 hour)
研究者
Hyo-Seok Na
Associate Professor
Seoul National University Bundang Hospital
