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Brain Activity and Changes in Consciousness During General Anesthesia
Sponsor: Beijing Chao Yang Hospital
Summary
This study aims to investigate how general anesthetics alter brain activity and consciousness across different age groups. The study will evaluate four anesthetic agents with different mechanisms of action: propofol, remimazolam, esketamine, and dexmedetomidine. Electroencephalography (EEG) will be recorded during wakefulness, anesthetic induction, loss of responsiveness, and recovery of responsiveness to characterize changes in brain activity and brain network dynamics. The study includes children aged 6-12 years undergoing surgery, healthy young adults aged 20-40 years, and healthy older adults aged 65-80 years. Resting-state EEG will be used to examine changes in brain rhythms, temporal and spatial brain dynamics, and network organization across different levels of consciousness. In a subgroup of young adult participants, auditory stimuli will also be presented continuously to investigate how the brain processes sounds and meaningful information as consciousness decreases and subsequently recovers. The study will compare EEG changes across anesthetic agents, age groups, and states of consciousness. It will also evaluate the timing of loss and recovery of responsiveness, anesthetic dose-response relationships, and adverse events. The overall goal is to identify brain activity patterns associated with anesthesia-induced changes in consciousness and to provide a scientific basis for improved monitoring of consciousness and anesthetic depth.
Official title: Mechanism Exploration of General Anesthesia-Induced Altered Consciousness Via Cortical-Thalamic Network Modulation and Development of a Precision Anesthesia Depth Monitoring Device
Key Details
Gender
All
Age Range
6 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-09
Completion Date
2028-12
Last Updated
2026-09-23
Healthy Volunteers
Yes
Interventions
Propofol (Group P)
Propofol will be administered by target-controlled infusion in young and older healthy volunteers. The plasma target concentration will be increased by 0.5 μg/mL every 5 minutes, up to a maximum of 5 μg/mL, until protocol-defined loss of responsiveness is achieved. Consciousness will be assessed every minute using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, and EEG will be recorded throughout anesthetic induction and recovery.
Remimazolam group
Remimazolam will be administered intravenously in young and older healthy volunteers at sequential infusion rates of 0.5, 1.0, 1.5, and 2.0 mg/kg/h, with each level maintained for 5 minutes, until protocol-defined loss of responsiveness is achieved. Consciousness will be assessed every minute using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, and EEG will be recorded throughout anesthetic induction and recovery.
Esketamine group
Esketamine will be administered intravenously in young and older healthy volunteers. The infusion rate will be increased by 0.10 mg/kg/h every 5 minutes, up to a maximum of 0.50 mg/kg/h, until protocol-defined loss of responsiveness is achieved. Consciousness will be assessed every minute using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, and EEG will be recorded throughout anesthetic induction and recovery.
Dexmedetomidine group
Dexmedetomidine will be administered intravenously in young and older healthy volunteers with stepwise increases in the infusion rate of 0.1 μg/kg/h, up to a maximum of 0.7 μg/kg/h, until protocol-defined loss of responsiveness is achieved. Consciousness will be assessed every minute using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, and EEG will be recorded throughout anesthetic induction and recovery.
Locations (1)
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, China