此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia

2026年9月2日 更新者：Ruijin Hospital

General anesthesia emergence is a critical transition during which patients recover from an anesthetic-induced unconscious state to consciousness. This period is associated with various early postoperative complications, including emergence agitation, postoperative nausea and vomiting, delayed recovery, and impaired recovery quality in the Post-Anesthesia Care Unit (PACU). Although total intravenous anesthesia (TIVA) and inhalational anesthesia (IA) are widely used maintenance strategies, differences in their effects on cerebral recovery patterns during emergence remain incompletely understood.

Conventional assessments of emergence, such as time to eye opening, extubation time, and clinical sedation assessments, mainly reflect behavioral recovery and cannot directly characterize the dynamic process of cerebral functional recovery. Electroencephalography (EEG) provides continuous and non-invasive measurement of cortical activity and may enable objective characterization of anesthetic emergence.

Previous studies suggest that emergence from anesthesia involves dynamic transitions among distinct EEG states rather than a simple reversal of anesthetic induction, and specific EEG trajectories may be associated with abnormal emergence and PACU delirium. Therefore, this single-center prospective observational cohort study aims to continuously collect emergence-phase EEG data from patients receiving TIVA or IA without altering clinical anesthesia management. The study will compare EEG trajectory characteristics, spectral features, and aperiodic parameters between different anesthesia maintenance modalities and explore their associations with emergence quality and early postoperative complications.

This study may provide further insights into neurophysiological patterns of anesthetic emergence and support future optimization of emergence monitoring and perioperative management.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

140

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

学习地点

  • 中国
      • Shanghai、中国
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • 接触：

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

接受健康志愿者

是的

取样方法

非概率样本

研究人群

This study will enroll adult patients aged 18-60 years who are scheduled to undergo elective non-cardiac and non-neurosurgical surgery under general anesthesia. Participants will receive routine clinical anesthesia management, and the choice of total intravenous anesthesia or inhalational anesthesia will be determined by the attending anesthesiologist according to clinical practice.

描述

Inclusion criteria

  1. Adults aged 18-60 years.
  2. Patients classified as American Society of Anesthesiologists (ASA) physical status I-III.
  3. Patients scheduled to undergo elective non-cardiac and non-neurosurgical surgery under general anesthesia.
  4. Expected duration of surgery ≥60 minutes.
  5. Expected intraoperative maintenance anesthesia with either total intravenous anesthesia (TIVA) or inhalational anesthesia .
  6. Patients who understand the study procedures and voluntarily provide written informed consent.

Exclusion Criteria

  1. History of central nervous system disorders, including epilepsy, Parkinson's disease, dementia, previous stroke with residual neurological deficits, or other clinically significant neurological diseases.
  2. Long-term use (≥4 weeks) of sedative-hypnotic drugs, antidepressants, antipsychotic medications, or other medications that may significantly affect central nervous system function.
  3. Pre-existing cognitive impairment or severe visual/hearing impairment preventing assessment of recovery of consciousness.
  4. Skin lesions, trauma, or other conditions affecting placement of frontal EEG electrodes.
  5. Emergency surgery, neurosurgery, cardiac surgery, planned deep sedation with postoperative intubation, or direct transfer to the intensive care unit after surgery.
  6. Severe intraoperative adverse events, including cardiac arrest, malignant hyperthermia, severe allergic reactions, major bleeding, or situations requiring substantial changes in the planned anesthesia maintenance strategy.
  7. Body mass index (BMI) ≥30 kg/m² or ≤18 kg/m².
  8. Refusal to participate or withdrawal of informed consent during the study.1. Adults aged 18-60 years, with no restriction on sex.

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
Inhalational anesthesia
其他：无干预：观察队列
无干预：观察队列
Total intravenous anesthesia
其他：无干预：观察队列
无干预：观察队列

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
EEG trajectories during emergence from anesthesia
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation.
Frontal EEG recordings will be analyzed to characterize spectral activity and its temporal evolution during emergence from general anesthesia. Prespecified EEG parameters will include delta-band spectral power and alpha/spindle-band spectral power derived from power spectral density estimates. These spectral features will be used to characterize EEG states and transitions during emergence, including state occupancy, transition timing, and transition sequences.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation.

次要结果测量

结果测量
措施说明
大体时间
EEG spectral power characteristics
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Frontal EEG recordings will be obtained during emergence from general anesthesia. The EEG will be segmented into consecutive prespecified epochs, and spectral analysis will be performed for each segment. Power spectral density will be calculated within the following frequency bands: delta, 0.5-4 Hz; theta, 4-8 Hz; alpha/spindle, 8-13 Hz; beta, 13-30 Hz; and gamma, 30-45 Hz. Absolute power and relative power will be calculated for each frequency band. Relative power will be defined as the power within each frequency band divided by the total spectral power across the prespecified analysis frequency range. The alpha-to-delta power ratio, alpha peak frequency, and alpha peak power will also be calculated. Gamma-band findings will be considered exploratory because of possible electromyographic contamination.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic exponent of the EEG power spectrum
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
The aperiodic exponent will be estimated from frontal EEG power spectra using a prespecified spectral parameterization method that separates periodic spectral peaks from the aperiodic 1/f-like background.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic offset of the EEG power spectrum
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
The aperiodic offset will be estimated from frontal EEG power spectra using a prespecified spectral parameterization method that separates periodic spectral peaks from the aperiodic 1/f-like background.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Auxiliary EEG and monitor-derived parameters during emergence
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Additional EEG-derived and monitor-generated parameters will be assessed during emergence from general anesthesia. Spectral edge frequency 90% (SEF90) will be calculated as the frequency below which 90% of the total EEG spectral power within the prespecified analysis frequency range is contained. In addition, the Ai Index and electromyographic (EMG) index generated by the EEG monitoring system will be recorded continuously during emergence.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Length of stay in the postanesthesia care unit
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Duration from admission to discharge from the postanesthesia care unit.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aldrete score at PACU discharge
大体时间：Before discharge from the postanesthesia care unit.
Recovery status will be assessed using the Aldrete score at discharge from the postanesthesia care unit.
Before discharge from the postanesthesia care unit.
Richmond Agitation-Sedation Scale score at PACU discharge
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Level of agitation and sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at PACU discharge.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Pain intensity measured using the Numeric Rating Scale at PACU discharge
大体时间：From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS) at PACU discharge, with higher scores indicating greater pain intensity.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal 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。

赞助

Ruijin 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 (估计的)

2026年8月24日

初级完成 (估计的)

2027年3月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • MR-31-26-069242

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.

订阅