跳至主要内容
临床试验/NCT07410702
NCT07410702招募中不适用

EEG Signatures of Unconsciousness Induced by Anesthetic Agents and Their Dynamics Across the Consciousness Continuum

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Identification of EEG Biomarkers for Sedation, Adequate Anesthesia, and Deep Anesthesia During Induction

研究概览

简要总结

This prospective observational study is designed to investigate and compare the dynamic features of whole-brain electroencephalogram (EEG) during the induction of unconsciousness using various anesthetic agents with distinct pharmacological mechanisms. The primary objective is to identify common, drug-agnostic EEG biomarkers of anesthetic depth and to develop a novel, universal assessment system that addresses the limitations of the currently prevalent Bispectral Index (BIS), which demonstrates variable sensitivity across different anesthetics.

Approximately 250 adult patients (ASA I-II) scheduled for elective surgery under general anesthesia will be enrolled. Patients will undergo preoperative cognitive assessment prior to induction. During anesthesia induction, 32-channel EEG signals will be continuously recorded alongside BIS values and behavioral state assessments using the MOAA/S scale as the reference standard.

Patients will receive one of the following intravenous anesthetics for induction: Propofol, Ciprofol, Remimazolam, Esketamine, or Fospropofol. Features will be extracted from the preprocessed EEG data. Statistical analyses will compare these features across drug groups and in relation to behavioral state transitions. Machine learning models (e.g., Random Forest) will then be trained to classify states of consciousness based on the extracted EEG features, with model performance validated against the behavioral gold standard.

The study aims to establish a more robust and generalizable neurophysiological framework for monitoring anesthetic depth, potentially improving the precision and safety of clinical anesthesia management.

详细描述

The aim of the study is to identify and validate common whole-brain EEG biomarkers that accurately track the transition between conscious states (wakefulness, sedation, unconsciousness) across five intravenous anesthetics with distinct mechanisms of action: Propofol, Ciprofol, Remimazolam, Esketamine, and Fospropofol.

Design:

This is a single-center, prospective, observational cohort study. Consecutive eligible patients will be enrolled and grouped based on the clinical choice of anesthetic drug used for induction of general anesthesia. Data analysis will be performed by researchers blinded to the group allocation during the feature extraction and model development phases.

Approximately 250 adult patients (aged ≥18 years) scheduled for elective surgery under general anesthesia at Tongji Hospital, Wuhan, China, will be recruited between April 2026 and December 2027. Participants must have an ASA physical status of I or II, normal cognitive function (MMSE score ≥24), and provide written informed consent.

Interventions and Procedures:

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Scheduled to undergo elective surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
  • American Society of Anesthesiologists (ASA) Physical Status Class I to III.
  • Preoperative Mini-Mental State Examination (MMSE) score ≥ 24, indicating normal cognitive function.
  • Body mass index (BMI) ≤ 30 kg/m².
  • Ability to understand the study and provide written informed consent.

排除标准

  • History of drug abuse or dependence.
  • Known major neurological disorders (e.g., epilepsy, stroke, neurodegenerative diseases).
  • History of major psychiatric disorders.
  • Known or suspected pregnancy.
  • Inability to provide informed consent due to cognitive impairment, language barrier, or any other reason.

研究组 & 干预措施

General Anesthesia

Adult patients requiring general anesthesia for surgical procedures

干预措施: Anesthetic Agents (Drug)

结局指标

主要结局

Identification of EEG Biomarkers for Sedation, Adequate Anesthesia, and Deep Anesthesia During Induction

时间窗: From 2026.02.20 to 2026.12.31

Identification of two or more EEG biomarkers associated with three distinct levels of consciousness (sedation, adequate anesthesia depth, and deep anesthesia) during the induction of general anesthesia.

Identification of Common EEG Biomarkers of Consciousness Across Anesthetic Agents

时间窗: From 2026.02.20 to 2026.12.31

dentification of common EEG biomarkers of consciousness that are consistent across two or more anesthetic agents with differing pharmacological mechanisms.

次要结局

  • Classification Performance of Novel EEG Biomarkers Compared to BIS for Assessing Anesthesia Depth(From 2027.01.01 to 2027.10.31)
  • Development and Validation of a Mechine learning Model(From 2027.01.01 to 2027.10.31)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hua Zheng

Associate professor

Huazhong University of Science and Technology

研究点 (1)

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