The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness

NCT07145697 | Recruiting Phase 4

• 1 other identifier: Mechanisms of Consciousness
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Consciousness, Level Altered

Outcome Measures

Primary Outcomes (1)

• Stereo-electroencephalography

  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

  through test completion, an average of 3 hours

• The complexity

  through test completion, an average of 3 hours

• Phase-amplitude coupling (PAC)

  through test completion, an average of3 hours.

• Directional connectivity

  through test completion, an average of 3 hours

Study Arms (2)

Sleep

NO INTERVENTION

Recordering electroencephalograms during nighttime natural sleep.

Dexmedetomidine

EXPERIMENTAL

Escalating concentrations until loss of responsiveness

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Escalating concentrations until loss of responsiveness

Dexmedetomidine

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

General hospital of southern theater command, PLA

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CN (1)