Mechanism Exploration of General Anesthesia-Induced Altered Consciousness Via Cortical-Thalamic Network Modulation and Development of a Precision Anesthesia Depth Monitoring Device
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Changes in Resting-State Quantitative EEG Measures Across Behavioral Responsiveness States
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must belong to one of the following prespecified age groups: children aged 6-12 years, young adults aged 20-40 years, or older adults aged 65-80 years.
- •Children must be surgical patients undergoing general anesthesia. Young adult and older adult participants will be healthy volunteers.
- •American Society of Anesthesiologists (ASA) physical status I; older adult participants may have ASA physical status II.
- •Written informed consent must be obtained from all adult participants and surgical patients as applicable. For pediatric participants, written informed consent must be provided by a parent or legal guardian.
排除标准
- •History of neuropsychiatric disorders, including epilepsy, dementia, or other relevant neurological or psychiatric diseases.
- •Known hearing impairment or physical impairment that may interfere with completion of the study procedures or tasks.
- •History of allergy to propofol, benzodiazepines, or other anesthetic agents used in the study.
- •Long-term use of sedative or analgesic medications for more than 1 month. Disturbed sleep pattern within 14 days before the study, including shift work or insomnia.
- •Communication difficulties or inability to cooperate with EEG data acquisition.
研究组 & 干预措施
Remimazolam Group
Participants in this arm will receive remimazolam. In young and older healthy volunteers, remimazolam will be administered intravenously 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 loss of responsiveness is achieved. EEG will be recorded during wakefulness, anesthetic induction, loss of responsiveness, and recovery. Pediatric surgical participants in this group will undergo EEG recording during anesthesia in the operating room.
干预措施: Remimazolam group (Drug)
Propofol Group
Participants in this arm will receive propofol. In young and older healthy volunteers, propofol will be administered by target-controlled infusion, with the plasma target concentration increased by 0.5 μg/mL every 5 minutes up to a maximum of 5 μg/mL to induce loss of responsiveness. EEG will be recorded during wakefulness, anesthetic induction, loss of responsiveness, and recovery. Pediatric surgical participants in this group will undergo EEG recording during anesthesia in the operating room.
干预措施: Propofol (Group P) (Drug)
Dexmedetomidine Group
Participants in this arm will receive dexmedetomidine. In young and older healthy volunteers, dexmedetomidine will be administered intravenously with stepwise increases of 0.1 μg/kg/h, up to a maximum of 0.7 μg/kg/h, to induce loss of responsiveness. EEG will be recorded during wakefulness, anesthetic induction, loss of responsiveness, and recovery. Pediatric surgical participants in this group will undergo EEG recording during anesthesia in the operating room.
干预措施: Dexmedetomidine group (Drug)
Esketamine Group
Participants in this arm will receive esketamine. In young and older healthy volunteers, esketamine will be administered intravenously with the infusion rate increased by 0.10 mg/kg/h every 5 minutes, up to a maximum of 0.50 mg/kg/h, to induce loss of responsiveness. EEG will be recorded during wakefulness, anesthetic induction, loss of responsiveness, and recovery. Pediatric surgical participants in this group will undergo EEG recording during anesthesia in the operating room.
干预措施: Esketamine group (Drug)
结局指标
主要结局
Changes in Resting-State Quantitative EEG Measures Across Behavioral Responsiveness States
时间窗: From the start of the 10-minute awake baseline through anesthetic induction, loss-of-responsiveness maintenance, emergence, and 30 minutes after recovery of responsiveness
Continuous resting-state EEG will be quantified across awake baseline, anesthetic induction, loss of responsiveness, maintenance, emergence, and recovery. Prespecified measures include delta power (0.5-4 Hz), alpha power (8-12 Hz), theta/alpha power ratio, slow-wave index (SWI), burst suppression ratio (BSR), autocorrelation window at the first zero crossing (ACW-0), EEG complexity (gMLZC), and alpha-band (8-13 Hz) functional connectivity/network measures, including wPLI/dwPLI² and weighted global efficiency. Each measure will be analyzed separately.
Changes in Auditory-Evoked ERP and Time-Frequency EEG Measures Across Behavioral Responsiveness States
时间窗: From the start of the 10-minute awake baseline through anesthetic induction, loss of responsiveness, maintenance, emergence, and at least 10 minutes after recovery of responsiveness
Auditory-evoked EEG will be quantified across awake baseline, anesthetic induction, loss of responsiveness, maintenance, emergence, and recovery. Event-related potential (ERP) measures include N100, mismatch negativity (MMN), N400, and P300 amplitudes and their state-related temporal dynamics. Stimuli include pure tones, white noise, characters, words, sentences, another person's name, and the participant's own name. Time-frequency measures include event-related theta-band activity (4-8 Hz), alpha-band activity (8-12 Hz), and intertrial phase coherence. Source-space analyses will localize N400 and P300 generators, and single-trial ERP amplitudes will be analyzed in relation to behavioral responsiveness. Each measure will be analyzed separately.
次要结局
未报告次要终点