Consciousness, Level AlteredPhase 4NCT07145697
The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness
A Phase 4 study testing Dexmedetomidine in people with Consciousness, Level Altered, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
In the field of general anesthesia research, the neural mechanism underlying the loss of consciousness has long been a highly core issue. It remains unclear what consciousness is and how it emerges from brain activity. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Consciousness, Level Altered
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Phase 4
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range: 1 - 65 years old
- BMI: 18.5 - 25.0 kg/m²
- ASA physical status classification: I - III
- Patients diagnosed with drug - refractory epilepsy who, after long - term monitoring of epileptic seizures, require stereo-electroencephalography (SEEG) electrode implantation based on the clinical need for monitoring their epilepsy.
- Patients voluntarily participate in this study and sign a written informed consent form.
Who cannot join
- Patients with severe arrhythmia or other organic heart diseases;
- Patients with comorbid obstructive sleep apnea-hypopnea syndrome (OSAHS);
- Patients with hepatic or renal dysfunction; those with a history of immunodeficiency diseases , or a history of cancer/malignant tumors, or a history of autoimmune diseases, or severe cardiovascular and cerebrovascular diseases, or other diseases that may significantly reduce life expectancy;
- Patients with any history of diseases that may affect protocol compliance (such as severe mental disorders, disturbance of consciousness; cognitive dysfunction, drug abuse or addiction, etc.);
- Pregnant or lactating women, or those of childbearing potential who are unwilling/unable to take effective contraceptive measures;
- Patients with known allergies to the ingredients contained in the drugs used in this study;
- Patients who have participated in any drug clinical trial within 6 months before the screening examination;
- Patients who are deemed unsuitable to participate in this study by the researcher.
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
General hospital of southern theater command, PLA
Guangzhou, Guangdong, 510000
Jing He, 88653504, hejing0096@163.com
About this study
In the field of general anesthesia research, the neural mechanism underlying the loss of consciousness has long been a highly core issue. It remains unclear what consciousness is and how it emerges from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what happens in the brain when consciousness is lost and when it returns.
Dexmedetomidine, a widely used drug in clinical anesthetic practice, plays an important role in the anesthetic process due to its unique pharmacological properties. It hardly causes respiratory depression during the sedative and hypnotic process, which makes it occupy an important position in clinical anesthetic regimens.
Read more
The emergence of stereoelectroencephalography (SEEG) technology has brought new opportunities for research on anesthesia mechanisms. Compared with traditional electroencephalographic (EEG), SEEG can directly penetrate into deep brain structures to record electrical activities, enabling precise localization of brain regions closely related to consciousness regulation.
At present, although there have been some studies on the effects of dexmedetomidine on EEG activities, there are still many deficiencies. Most studies have focused on simple spectral analysis of EEG signals or observations of limited brain regions, lacking comprehensive multi-dimensional research on functional connectivity between brain regions, microstates, and complexity. Through monitoring key brain regions, the SEEG technology can obtain more targeted and accurate information, thereby providing strong support for comprehensively revealing the neural mechanisms of dexmedetomidine-induced loss of consciousness.
- Conditions
- Consciousness, Level Altered
- Being tested
- Dexmedetomidine
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Escalating concentrations until loss of responsiveness
| Study group | Role | What they receive |
|---|---|---|
| Sleep | No intervention | Recordering electroencephalograms during nighttime natural sleep. |
| Dexmedetomidine | Experimental | Escalating concentrations until loss of responsiveness Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stereo-electroencephalography
Measured: After the patient has completed the monitoring of epileptic seizures due to clinical needs, they can participate in this test. Through test completion, an average of 3 hours.
Secondary outcomes (4)
Functional connectivity
permutation mutual information (PMI); stereo-electroencephalography assessment parameter
Measured: through test completion, an average of 3 hours
The complexity
examined by permutation entropy (PE); stereo-electroencephalography assessment parameter
Measured: through test completion, an average of 3 hours
Phase-amplitude coupling (PAC)
PAC is used to illuminate cross-frequency coordination in neurophysiological activity of electroencephalogram. stereo-electroencephalography assessment parameter
Measured: through test completion, an average of3 hours.
Directional connectivity
symbolic conditional mutual information (SCMI) and directionality index (DI); stereo-electroencephalography assessment parameter
Measured: through test completion, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness, Level AlteredStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145697
- Sponsor's protocol ID
- Mechanisms of Consciousness
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness
- ClinicalTrials.gov ID
- NCT07145697
- Acronym / sponsor ID
- Mechanisms of Consciousness
- Conditions
- Consciousness, Level Altered
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
In the field of general anesthesia research, the neural mechanism underlying the loss of consciousness has long been a highly core issue. It remains unclear what consciousness is and how it emerges from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what happens in the brain when consciousness is lost and when it returns.
Dexmedetomidine, a widely used drug in clinical anesthetic practice, plays an important role in the anesthetic process due to its unique pharmacological properties. It hardly causes respiratory depression during the sedative and hypnotic process, which makes it occupy an important position in clinical anesthetic regimens.
The emergence of stereoelectroencephalography (SEEG) technology has brought new opportunities for research on anesthesia mechanisms. Compared with traditional electroencephalographic (EEG), SEEG can directly penetrate into deep brain structures to record electrical activities, enabling precise localization of brain regions closely related to consciousness regulation.
At present, although there have been some studies on the effects of dexmedetomidine on EEG activities, there are still many deficiencies. Most studies have focused on simple spectral analysis of EEG signals or observations of limited brain regions, lacking comprehensive multi-dimensional research on functional connectivity between brain regions, microstates, and complexity. Through monitoring key brain regions, the SEEG technology can obtain more targeted and accurate information, thereby providing strong support for comprehensively revealing the neural mechanisms of dexmedetomidine-induced loss of consciousness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep | No intervention | –Recordering electroencephalograms during nighttime natural sleep. |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineEscalating concentrations until loss of responsiveness |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age range: 1 - 65 years old
- BMI: 18.5 - 25.0 kg/m²
- ASA physical status classification: I - III
- Patients diagnosed with drug - refractory epilepsy who, after long - term monitoring of epileptic seizures, require stereo-electroencephalography (SEEG) electrode implantation based on the clinical need for monitoring their epilepsy.
- Patients voluntarily participate in this study and sign a written informed consent form.
Key exclusion criteria (8 listed)
- Patients with severe arrhythmia or other organic heart diseases;
- Patients with comorbid obstructive sleep apnea-hypopnea syndrome (OSAHS);
- Patients with hepatic or renal dysfunction; those with a history of immunodeficiency diseases , or a history of cancer/malignant tumors, or a history of autoimmune diseases, or severe cardiovascular and cerebrovascular diseases, or other diseases that may significantly reduce life expectancy;
- Patients with any history of diseases that may affect protocol compliance (such as severe mental disorders, disturbance of consciousness; cognitive dysfunction, drug abuse or addiction, etc.);
- Pregnant or lactating women, or those of childbearing potential who are unwilling/unable to take effective contraceptive measures;
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 |
|---|---|---|
| DexmedetomidineEscalating concentrations until loss of responsiveness | Drug | Dexmedetomidine |
Primary outcome
Stereo-electroencephalography
Time frame: After the patient has completed the monitoring of epileptic seizures due to clinical needs, they can participate in this test. Through test completion, an average of 3 hours.
4 secondary outcomes
Functional connectivity
Time frame: through test completion, an average of 3 hours
The complexity
Time frame: through test completion, an average of 3 hours
Phase-amplitude coupling (PAC)
Time frame: through test completion, an average of3 hours.
Directional connectivity
Time frame: through test completion, an average of 3 hours
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 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Consciousness, Level Altered, run by Guangzhou General Hospital of Guangzhou Military Command 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 5 inclusion and 8 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 27 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stereo-electroencephalography (time frame: After the patient has completed the monitoring of epileptic seizures due to clinical needs, they can participate in this test. Through test completion, an average of 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.