Correlating EEG Dynamics With Consciousness Alteration Under Anesthesia

NCT07410702 | Recruiting

• 1 other identifier: TJ-IRB202601004
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Altered State of Consciousness; General Anesthetics

Keywords

General Anesthetics; Electroencephalography; Neural correlates of consciousness; Consciousness monitoring

Outcome Measures

Primary Outcomes (2)

• 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.

  From 2026.02.20 to 2026.12.31

• 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.

  From 2026.02.20 to 2026.12.31

Secondary Outcomes (2)

• 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

Study Arms (1)

General Anesthesia

Adult patients requiring general anesthesia for surgical procedures

Drug: Anesthetic Agents

Interventions

Anesthetic Agents DRUG

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

General Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery requiring general anesthesia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• Liang Z, Tang B, Chang Y, Wang J, Li D, Li X, Wei C. State-related Electroencephalography Microstate Complexity during Propofol- and Esketamine-induced Unconsciousness. Anesthesiology. 2024 May 1;140(5):935-949. doi: 10.1097/ALN.0000000000004896.

  PMID: 38157438 RESULT

MeSH Terms

Interventions

Anesthetics

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Pu Zhou, PhD.

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zheng, MD. & PhD.

CONTACT

0086-27-83663173; hzheng@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-02

Locations

CN (1)