Correlating EEG Dynamics With Consciousness Alteration Under Anesthesia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHuazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients scheduled for elective surgery requiring general anesthesia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Anesthetic Agents

    Drug

    Loss of consciousness was induced in humans using five distinct general anesthetic agents: propofol, ciprofol, remimazolam, esketamine, and fospropofol

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: General Anesthesia1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From 2026.02.20 to 2026.12.31
2

Identification of Common EEG Biomarkers of Consciousness Across Anesthetic Agents

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

Time frame
From 2026.02.20 to 2026.12.31

Secondary outcomes

1

Classification Performance of Novel EEG Biomarkers Compared to BIS for Assessing Anesthesia Depth

1\. Comparison of the precision (hit rate) in classifying the three consciousness states sedation, adequate anesthesia depth, and deep anesthesia) between the newly identified EEG biomarkers and the Bispectral Index (BIS) for one or more anesthetic agents.

Time frame
From 2027.01.01 to 2027.10.31
2

Development and Validation of a Mechine learning Model

Development and validation of a tree-based ensemble machine learning model using 70% of the dataset for training and 30% for testing, including evaluation of its accuracy and the area under the receiver operating characteristic curve (AUC-ROC)

Time frame
From 2027.01.01 to 2027.10.31

Other outcomes

Sponsors and contacts

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