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临床试验/NCT03251651
NCT03251651已完成不适用

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

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 748 人开始时间: 2017年6月15日最近更新:
适应症
干预措施

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

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

Experimental

Patient who received propofol during the operation

干预措施: Propofol (Drug)

DEX

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Seok Na

Associate Professor

Seoul National University Bundang Hospital

研究点 (1)

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