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Effects of Preoperative Sleep Disorders on Perioperative Anesthesia Depth and Recovery Quality in Patients Undergoing Noncardiac Surgery

2026年6月29日 更新者：General Hospital of Ningxia Medical University

Effects of Preoperative Sleep Disorders on Perioperative Anesthesia Depth and Recovery Quality in Patients Undergoing Noncardiac Surgery: A Single-Center, Prospective, Observational Cohort Study

A Single-Center, Prospective Observational Cohort Study Comparing Perioperative Electroencephalographic Anesthesia Depth Parameters (Electroencephalographic Index, SE/RE Entropy, Burst Suppression Ratio) Between Patients With Preoperative Sleep Disorders and Those Without; To Identify the Independent Effects of Preoperative Sleep Disorders on the Speed of Electroencephalographic Recovery During Emergence, Electroencephalographic Status at Extubation, Intra-PACU Electroencephalographic Fluctuations, and Quality of Emergence.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Preoperative sleep disorder is a common perioperative comorbidity. It impairs central nervous system stability and anesthetic drug metabolism, delays postoperative recovery, and is strongly associated with delayed emergence from general anesthesia, emergence agitation, and postoperative cognitive decline. Electroencephalographic (EEG) monitoring enables continuous, quantitative assessment of anesthetic depth (including EEG index, entropy, and burst suppression ratio), which can reflect central nervous depression more sensitively than conventional vital sign monitoring. To date, there is a lack of evidence based on complete preoperative-intraoperative-postoperative continuous EEG data to clarify the correlations between sleep disorders, anesthetic depth, and emergence quality. This prospective cohort study will collect full-course EEG parameters throughout the perioperative period to identify the effects of preoperative sleep disorders on the stability of anesthetic depth, EEG recovery during emergence, and adverse emergence events, so as to provide evidence-based references for perioperative cerebral protection and precision anesthetic management.

Primary Outcome Measures Preoperative & Postoperative Polysomnography (PSG) indicators: Sleep Efficiency Index (SEI), Total Sleep Time (TST), Arousal Index (AI), and the proportional percentages of N1, N2, N3 stages within NREM sleep and REM sleep; assessments conducted on the night after surgery, postoperative Day 1 and postoperative Week 1.Intraoperative EEG parameters: mean value of EEG index, minimum EEG index value, cumulative duration when EEG index < 40, maximum Burst Suppression Ratio (BSR).Emergence-phase EEG indicators: recovery time of EEG index, EEG index at extubation, standard deviation of EEG fluctuation in Post-Anesthesia Care Unit (PACU).Emergence quality indicators: extubation time, PACU length of stay, incidence of emergence agitation.

Serum Brain-Derived Neurotrophic Factor (BDNF) levels collected at preoperative, intraoperative and postoperative time points.

研究类型

观察性的

注册 (估计的)

80

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。

学习联系方式

  • 姓名：Na Zhao, Doctoral Candidate
  • 电话号码：86-951-674-3252
  • 邮箱：18995096494@163.com

研究联系人备份

  • 姓名：Li Xin Ni, Doctoral
  • 电话号码：86-951-674-3252

学习地点

  • 中国
    • Ningxia
      • Yinchuan、Ningxia、中国、750001
        • 招聘中
        • General Hospital of Ningxia Medical University
        • 接触：
        • 接触：
          • Li Xin Ni, Doctoral
          • 电话号码：86-951-674-3252

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

概率样本

研究人群

Patients scheduled for elective non-cardiac surgery under general anesthesia at our hospital will be enrolled in this study.

描述

Inclusion Criteria:

  1. - Aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ;
  2. Elective non-cardiac surgery with an expected operative duration longer than 2 hours;
  3. Preoperative Mini-Mental State Examination (MMSE) score ≥ 24;
  4. Completion of the Pittsburgh Sleep Quality Index (PSQI) assessment 1 day before surgery;
  5. Absence of severe cardiac, hepatic, renal or cerebral diseases, and no history of psychiatric or neurological disorders;
  6. Voluntary provision of written informed consent.

Exclusion Criteria:

  1. Preoperative severe cognitive dysfunction, history of traumatic brain injury or stroke;
  2. Long-term regular use of sedative-hypnotics, antidepressants or antipsychotics;
  3. Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ < 90% lasting for more than 5 minutes);
  4. Inability to cooperate with EEG monitoring or scale evaluation;
  5. Pregnancy or breastfeeding status.

Drop-out Criteria :

  1. Cancellation of scheduled surgery/anesthesia or postoperative admission to the intensive care unit (ICU);
  2. Patient withdrawal of study participation;
  3. Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ < 90% lasting for more than 5 minutes);
  4. Development of severe postoperative complications;
  5. Incomplete data collection or voluntary trial withdrawal.

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
Exposed cohort (sleep disorder group)
Patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥7.
组合产品：Exposed cohort (sleep disorder group)
All participants receive standardized sevoflurane-based general anesthesia for elective non-cardiac surgery. Continuous perioperative electroencephalographic (EEG) monitoring is performed throughout induction, maintenance and emergence phase. Serial scale assessments including PSQI, PSG, MMSE, NRS and delirium evaluation, as well as serial serum BDNF testing are conducted at designated perioperative time points. This cohort consists of patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 7, defined as preoperative sleep disorders.
Control cohort (non-sleep disorder group)
Patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score <7.
组合产品：Control cohort (non-sleep disorder group)
All participants receive identical standardized sevoflurane-based general anesthesia and continuous full-course EEG monitoring during elective non-cardiac surgery. Uniform perioperative scale assessments (PSQI, PSG, MMSE, NRS, postoperative delirium screening) and serial serum BDNF detection are completed at unified time nodes. This control cohort includes patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score < 7 without preoperative sleep disturbance.

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
Emergence Time
大体时间："perioperative"
Time to emergence from anesthesia:the time interval from discontinuation of anesthetics to patient awakening
"perioperative"
Time for recovery of EEG index
大体时间：Perioperative

The EEG index recovery time during emergence was monitored using the Misamo depth-of-anesthesia monitor. The awake judgment thresholds were set as SE ≥ 85 and RE ≥ 90.

Shorter recovery time indicates rapid elimination of anesthetic suppression in the cerebral cortex and smoother emergence; significantly prolonged recovery time suggests accumulation of anesthetics and excessive cerebral cortical suppression.

Start point: Discontinuation of maintenance doses of propofol, sevoflurane and remifentanil (rescue analgesics alone are not counted as the drug withdrawal start time).

End point: The EEG index steadily reaches the awake threshold without decline for 10p
Perioperative

次要结果测量

结果测量
措施说明
大体时间
Dosage of anesthetics:
大体时间：Perioperative
Dosage of anesthetics: total consumption of propofol, remifentanil and sevoflurane administered from anesthesia induction to emergence.
Perioperative
incidence of postoperative delirium
大体时间：CAM assessments were performed and recorded on postoperative Day 1, Day 3 and Day 7.

Postoperative delirium was assessed using the Confusion Assessment Method (CAM), which evaluates four dimensions: 1. acute fluctuating course; 2. inattention; 3. disorganized thinking; 4. altered level of consciousness. Higher CAM scores indicate more severe delirium.

Score 0: No delirium Score 1-2: Subsyndromal delirium (mild early stage) Score ≥3: Confirmed delirium Score 5-7: Severe delirium
CAM assessments were performed and recorded on postoperative Day 1, Day 3 and Day 7.
Numerical Rating Scale (NRS) pain score
大体时间：Pain scores were recorded immediately after surgery and daily from postoperative Day 1 to Day 7.
The Numerical Rating Scale (NRS) was adopted to evaluate the postoperative pain trend from postoperative Day 1 to Day 7. Higher NRS scores indicate more severe pain.Scores of 1-3 indicate mild pain, 4-7 moderate pain, and 8-10 severe pain.
Pain scores were recorded immediately after surgery and daily from postoperative Day 1 to Day 7.
Incidence of postoperative nausea and vomiting (PONV)
大体时间：PONV assessments were conducted upon emergence from anesthesia after surgery, and on postoperative Day 1, Day 2 and Day 3.
Grade 0 No nausea or vomiting Normal Grade 1 Nausea only, no vomiting or retching Mild PONV Grade 2 Retching or intermittent vomiting, less than 2 episodes Moderate PONV Grade 3 Frequent vomiting (≥2 episodes) with gastric contents ejection Severe PONV requiring pharmacological intervention For patients with Grade 2 or above PONV, the event shall be recorded in the Adverse Event section of the CRF, with a notation on whether antiemetics are administered.
PONV assessments were conducted upon emergence from anesthesia after surgery, and on postoperative Day 1, Day 2 and Day 3.

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。

赞助

General Hospital of Ningxia Medical University

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6月16日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ZN-2026-0615

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

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