Intraoperative Sedatives and Postoperative Deilirium
2022年7月7日 更新者：Hyo-Seok Na、Seoul National University Bundang Hospital
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
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.
研究概览
研究类型
介入性
注册 (实际的)
748
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Gyeonggi-do
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Seongnam-si、Gyeonggi-do、大韩民国、13620
- Seoul National University Bundang Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 至 90年 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PPF
Patient who received propofol during the operation
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Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0
μg/ml.
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实验性的：DEX
Patient who received dexmedetomidine during the operation
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Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml.
As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative delirium
大体时间：Within 3 day postoperatively
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The incidence of postoperative delirium
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Within 3 day postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Numerical rating scale
大体时间：Postoperative 24 hour
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Postoperative pain score
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Postoperative 24 hour
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Numerical rating scale
大体时间：Postoperative 48 hour
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Postoperative pain score
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Postoperative 48 hour
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Numerical rating scale
大体时间：Postoperative 72 hour
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Postoperative pain score
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Postoperative 72 hour
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Patient controlled analgesia (PCA)
大体时间：Postoperative 24 hour
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Amounts of the PCA consumption
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Postoperative 24 hour
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Patient controlled analgesia (PCA)
大体时间：Postoperative 48 hour
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Amounts of the PCA consumption
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Postoperative 48 hour
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Patient controlled analgesia (PCA)
大体时间：Postoperative 72 hour
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Amounts of the PCA consumption
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Postoperative 72 hour
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Rescue analgesics
大体时间：Postoperative 24 hour
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Amounts of the analgesics administered to manage the postoperative pain
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Postoperative 24 hour
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Rescue analgesics
大体时间：postoperative 48 hour
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Amounts of the analgesics administered to manage the postoperative pain
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postoperative 48 hour
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Rescue analgesics
大体时间：Postoperative 72 hour
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Amounts of the analgesics administered to manage the postoperative pain
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Postoperative 72 hour
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hyo-Seok Na, MD, PhD、Seoul National University Bundang Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月15日
初级完成 (实际的)
2021年10月15日
研究完成 (实际的)
2021年10月15日
研究注册日期
首次提交
2017年8月14日
首先提交符合 QC 标准的
2017年8月14日
首次发布 (实际的)
2017年8月16日
研究记录更新
最后更新发布 (实际的)
2022年7月11日
上次提交的符合 QC 标准的更新
2022年7月7日
最后验证
2022年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- B-1704/391-304
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Propofol的临床试验
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Kaohsiung Medical University Chung-Ho Memorial...Tri-Service General Hospital招聘中