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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Wei
- Número de telefone: +86 13810678936
- E-mail: changwei.wei@ccmu.edu.cn
Locais de estudo
-
-
-
Beijing, China, 100020
- Affiliated Beijing Chaoyang Hospital of Capital Medical University
-
Contato:
- Wei
- Número de telefone: +86 13810678936
- E-mail: changwei.wei@ccmu.edu.cn
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in Resting-State Quantitative EEG Measures Across Behavioral Responsiveness States
Prazo: 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. |
From the start of the 10-minute awake baseline through anesthetic induction, loss-of-responsiveness maintenance, emergence, and 30 minutes after recovery of responsiveness
|
|
Changes in Auditory-Evoked ERP and Time-Frequency EEG Measures Across Behavioral Responsiveness States
Prazo: 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. |
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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-ke-429
- L2510005 (Número de outro subsídio/financiamento: Beijing Natural Science Foundation - Capital Clinical Medical Innovation Joint Fund)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .