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临床试验/NCT07806903
NCT07806903尚未招募不适用

Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
EEG trajectories during emergence from anesthesia

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Total intravenous anesthesia

干预措施: No Intervention: Observational Cohort (Other)

Inhalational anesthesia

干预措施: No Intervention: Observational Cohort (Other)

结局指标

主要结局

EEG trajectories during emergence from anesthesia

时间窗: 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.

次要结局

  • EEG spectral power characteristics(From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation)
  • Aperiodic exponent of the EEG power spectrum(From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation)
  • Aperiodic offset of the EEG power spectrum(From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation)
  • Auxiliary EEG and monitor-derived parameters during emergence(From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation)
  • Length of stay in the postanesthesia care unit(From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation)
  • Aldrete score at PACU discharge(Before discharge from the postanesthesia care unit.)
  • Richmond Agitation-Sedation Scale score 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(From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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