Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients
2026年8月17日 更新者：Ruijin Hospital
Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients: A Single-Center, Prospective, Observational Cohort Study
To explore the relationship between plasma orexin levels during the recovery period of elderly patients undergoing general anesthesia and the occurrence of emergence delirium, and to evaluate its sensitivity and specificity as an objective diagnostic indicator for emergence delirium
研究概览
研究类型
观察性的
注册 (估计的)
150
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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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200025
- Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
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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
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
elderly patients undergoing general anesthesia
描述
Inclusion Criteria:
- Age is greater than or equal to 60 years old
- It is planned to undergo elective non-cardiac surgery under general anesthesia, with the expected operation duration being greater than or equal to 2 hours
- ASA I-III
Exclusion Criteria:
- There was a clear diagnosis of mental illness before the surgery (such as schizophrenia, severe depression, etc.) or the patient had been using antidepressants or anti-psychotic drugs for a long time.
- Preoperative presence of sleep-wake disorder-related diseases (such as narcolepsy, untreated moderate to severe obstructive sleep apnea syndrome, etc.) or long-term use of orexin receptor antagonists or agonists
- Preoperatively, there was severe liver dysfunction (Child-Pugh grade B or C), severe renal dysfunction (estimated glomerular filtration rate eGFR < 30 ml/min/1.73㎡), and severe anemia (Hb < 80 g/L)
- Perform deep sedation for extubation, plan to transfer to the ICU, or experience severe complications during the recovery period (such as anaphylactic shock, laryngospasm, etc.)
- There are cases where individuals have severe visual or hearing impairments, or are aphasic, and thus are unable to cooperate in completing the cognitive assessment.
- Having a history of alcohol abuse or drug addiction
- Emergency surgery, neurosurgery surgery
- The researchers considered it inappropriate to include in this study
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Emergence delirium group
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无干预：观察队列
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Non-Emergence delirium group
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无干预：观察队列
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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 |
|---|---|---|
|
Emergece Delirium
大体时间：During extubation and 20 minutes after extubation
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The CAM-ICU scale is administered at extubation and 20 minutes post-extubation during the PACU stay.
A positive finding at either time point is defined as emergence delirium.
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During extubation and 20 minutes after extubation
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Plasma Orexin
大体时间：30 minutes before anesthesia induction, after anesthesia induction but before surgical incision, 1 hour after surgical incision, at the time of discontinuation of volatile anesthetics, at extubation, and 20 minutes post-extubation
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Peripheral venous blood samples (3 mL each) are collected at six time points: 30 minutes before anesthesia induction, after induction but before incision, 1 hour after incision, at volatile anesthetic discontinuation, at extubation, and 20 minutes post-extubation.
Samples are placed in EDTA tubes, stored at 2-8°C, centrifuged at 3000 rpm for 15 minutes at 4°C, and the separated plasma is stored at -80°C.
Plasma orexin-A levels are measured by ELISA by technicians blinded to group assignment.
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30 minutes before anesthesia induction, after anesthesia induction but before surgical incision, 1 hour after surgical incision, at the time of discontinuation of volatile anesthetics, at extubation, and 20 minutes post-extubation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Delirium
大体时间：5 days post- operation
|
Postoperative delirium is assessed twice daily (8:00-10:00 and 18:00-20:00) from postoperative day 1 through day 5 using the CAM/CAM-ICU scale.
A positive finding on any assessment is defined as the occurrence of postoperative delirium.
The severity of delirium is evaluated using the DRS-R-98.
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5 days post- operation
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EEG power in alpha band
大体时间：From PACU admission to 20 minutes post-extubation
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EEG power in alpha band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
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EEG power in beta band
大体时间：From PACU admission to 20 minutes post-extubation
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EEG power in beta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
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EEG power in theta band
大体时间：From PACU admission to 20 minutes post-extubation
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EEG power in theta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
|
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EEG power in delta band
大体时间：From PACU admission to 20 minutes post-extubation
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EEG power in delta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
|
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。
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)
2026年3月31日
初级完成 (估计的)
2027年1月31日
研究完成 (估计的)
2027年2月5日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月24日
研究记录更新
最后更新发布 (实际的)
2026年8月18日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年7月1日
更多信息
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.