Altered State of ConsciousnessNCT07410702
Correlating EEG Dynamics With Consciousness Alteration Under Anesthesia
An observational study of Altered State of Consciousness and General Anesthetics, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Altered State of Consciousness, General Anesthetics
- What is being tested?
- Anesthetic Agents
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 20 Feb 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery requiring general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hua Zheng, Dr., 0086-27-83663173, hzheng@hust.edu.cn
About this study
Official title: EEG Signatures of Unconsciousness Induced by Anesthetic Agents and Their Dynamics Across the Consciousness Continuum
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.
Read more
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.
Read the detailed description
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:
All procedures represent standard clinical care; no experimental interventions are administered.
- Preoperative Assessment: Demographics, medical history, and MMSE score will be recorded.
- EEG and Behavioral Data Acquisition: During anesthesia induction, 32-channel EEG will be continuously recorded using a Greentek system with electrodes placed according to the international 10-20 system. Simultaneously, the BIS value (sensor placed infraorbitally)[referrence] and the patient's behavioral state will be recorded every 30 seconds using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale as the reference standard and the absence of the pupillary light reflex. Based on these behavioral responses, the depth of anesthesia will be categorized into three stages: sedation, adequate anesthesia depth, and deep anesthesia.
- Anesthetic Protocol: Induction of anesthesia will be performed by the attending anesthesiologist in accordance with standard institutional practice. One of the five study drugs will be administered as an intravenous bolus, with the induction dose maintained via continuous infusion for 5 minutes.
Data Processing and Analysis
- Data Curation: Data will be checked for quality, and epochs with artifacts or missing clinical data will be excluded.
- EEG Feature Extraction: Pre-processed EEG data will be analyzed to extract features including but not limited to power spectral density, permutation entropy, phase-lag entropy, and functional connectivity metrics.
- Data Analysis: During the induction of unconsciousness with five distinct general anesthetic agents, EEG biomarkers corresponding to transitions between three behavioral states-sedation, adequate anesthesia depth, and deep anesthesia-will be identified. The performance of these biomarkers in tracking depth of anesthesia will be quantitatively compared against that of the Bispectral Index (BIS).
- Machine Learning Modeling: The dataset will be split into training (70%) and validation (30%) sets. A tree-based ensemble model (e.g., Random Forest) will be trained to classify consciousness states based on EEG features. Model performance will be evaluated using AUC, accuracy, precision, and cross-validation.
- Being tested
- Anesthetic Agents
- Keywords
- General Anesthetics, Electroencephalography, Neural correlates of consciousness, Consciousness monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic AgentsDrug
Loss of consciousness was induced in humans using five distinct general anesthetic agents: propofol, ciprofol, remimazolam, esketamine, and fospropofol
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Adult patients requiring general anesthesia for surgical procedures Receives: Drug: Anesthetic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From 2026.02.20 to 2026.12.31
Secondary outcomes (2)
Classification Performance of Novel EEG Biomarkers Compared to BIS for Assessing Anesthesia Depth
- 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.
Measured: From 2027.01.01 to 2027.10.31
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)
Measured: From 2027.01.01 to 2027.10.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Feb 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Altered State of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zheng, Huazhong University of Science and Technology
- Investigators
- Pu Zhou, PhD., Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410702
- Sponsor's protocol ID
- TJ-IRB202601004
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38157438
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Signatures of Unconsciousness Induced by Anesthetic Agents and Their Dynamics Across the Consciousness Continuum
- ClinicalTrials.gov ID
- NCT07410702
- Acronym / sponsor ID
- TJ-IRB202601004
- Keywords
- General Anesthetics, Electroencephalography, Neural correlates of consciousness, Consciousness monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
All procedures represent standard clinical care; no experimental interventions are administered.
- Preoperative Assessment: Demographics, medical history, and MMSE score will be recorded.
- EEG and Behavioral Data Acquisition: During anesthesia induction, 32-channel EEG will be continuously recorded using a Greentek system with electrodes placed according to the international 10-20 system. Simultaneously, the BIS value (sensor placed infraorbitally)[referrence] and the patient's behavioral state will be recorded every 30 seconds using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale as the reference standard and the absence of the pupillary light reflex. Based on these behavioral responses, the depth of anesthesia will be categorized into three stages: sedation, adequate anesthesia depth, and deep anesthesia.
- Anesthetic Protocol: Induction of anesthesia will be performed by the attending anesthesiologist in accordance with standard institutional practice. One of the five study drugs will be administered as an intravenous bolus, with the induction dose maintained via continuous infusion for 5 minutes.
Data Processing and Analysis
- Data Curation: Data will be checked for quality, and epochs with artifacts or missing clinical data will be excluded.
- EEG Feature Extraction: Pre-processed EEG data will be analyzed to extract features including but not limited to power spectral density, permutation entropy, phase-lag entropy, and functional connectivity metrics.
- Data Analysis: During the induction of unconsciousness with five distinct general anesthetic agents, EEG biomarkers corresponding to transitions between three behavioral states-sedation, adequate anesthesia depth, and deep anesthesia-will be identified. The performance of these biomarkers in tracking depth of anesthesia will be quantitatively compared against that of the Bispectral Index (BIS).
- Machine Learning Modeling: The dataset will be split into training (70%) and validation (30%) sets. A tree-based ensemble model (e.g., Random Forest) will be trained to classify consciousness states based on EEG features. Model performance will be evaluated using AUC, accuracy, precision, and cross-validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | Drug: Anesthetic AgentsAdult patients requiring general anesthesia for surgical procedures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery requiring general anesthesia
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthetic AgentsLoss of consciousness was induced in humans using five distinct general anesthetic agents: propofol, ciprofol, remimazolam, esketamine, and fospropofol | Drug | General Anesthesia |
Primary outcome
Identification of EEG Biomarkers for Sedation, Adequate Anesthesia, and Deep Anesthesia During Induction
Time frame: 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
Time frame: 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.
2 secondary outcomes
Classification Performance of Novel EEG Biomarkers Compared to BIS for Assessing Anesthesia Depth
Time frame: From 2027.01.01 to 2027.10.31
Development and Validation of a Mechine learning Model
Time frame: From 2027.01.01 to 2027.10.31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 38157438Liang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pu Zhou, PhD. principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Altered State of Consciousness and General Anesthetics, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Zheng, MD. & PhD. (0086-27-83663173, hzheng@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of EEG Biomarkers for Sedation, Adequate Anesthesia, and Deep Anesthesia During Induction (time frame: From 2026.02.20 to 2026.12.31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.