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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Anesthetic Agents
DrugLoss of consciousness was induced in humans using five distinct general anesthetic agents: propofol, ciprofol, remimazolam, esketamine, and fospropofol
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.