Brain Activity and Changes in Consciousness During General Anesthesia
Mechanism Exploration of General Anesthesia-Induced Altered Consciousness Via Cortical-Thalamic Network Modulation and Development of a Precision Anesthesia Depth Monitoring Device
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Wei
- 电话号码:+86 13810678936
- 邮箱:changwei.wei@ccmu.edu.cn
学习地点
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Beijing、中国、100020
- Affiliated Beijing Chaoyang Hospital of Capital Medical University
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接触:
- Wei
- 电话号码:+86 13810678936
- 邮箱:changwei.wei@ccmu.edu.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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. |
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. |
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实验性的: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. |
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. |
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实验性的: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. |
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. |
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实验性的: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. |
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Resting-State Quantitative EEG Measures Across Behavioral Responsiveness States
大体时间:From the start of the 10-minute awake baseline through anesthetic induction, loss-of-responsiveness maintenance, emergence, and 30 minutes after recovery of responsiveness
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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. |
From the start of the 10-minute awake baseline through anesthetic induction, loss-of-responsiveness maintenance, emergence, and 30 minutes after recovery of responsiveness
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Changes in Auditory-Evoked ERP and Time-Frequency EEG Measures Across Behavioral Responsiveness States
大体时间: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
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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. |
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
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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