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Impact of EEG-guided Sevofluorane on Opioid Consumption and Quality of Awakening
Impact of EEG-guided Sevoflurane Titration on Opioid Consumption and Emergency Quality in Pediatric Patients Undergoing Surgery Without Regional Anesthesia
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Electroencephalography (EEG)-guided anesthetic titration has demonstrated significant clinical benefits in both pediatric and adult patients. However, proprietary EEG-based indices widely used for monitoring anesthetic depth are affected by patient age and the specific anesthetic agent used, limiting their validity and generalizability. More recently, titrating anesthetics based on a specific interpretation of EEG waveforms and their oscillatory patterns observed on the spectrogram has gained popularity.
Previous studies indicate that sevoflurane titration based on specific EEG waveforms and oscillatory patterns yields more substantial reductions in sevoflurane exposure than previously reported with proprietary EEG indices. Furthermore, reducing sevoflurane exposure decreases the incidence of EEG burst suppression, results in faster emergence times, and reduces emergence delirium.
However, most of these benefits have been reported in the context of surgeries where intraoperative antinociception was provided via central or peripheral nerve blocks, in the absence of increased intraoperative analgesic and opioid requirements. It remains unclear whether the benefits associated with reduced sevoflurane exposure are also observed in surgeries where intraoperative antinociception cannot be provided through regional blocks. In such cases, antinociception depends primarily on the co-administration of inhaled anesthetics and opioids. Therefore, the clinical benefits of decreasing sevoflurane exposure via electroencephalographic guidance must be weighed against the side effects of higher perioperative opioid requirements.
What will be the impact of strict titration of the hypnotic component using electroencephalography in a painful surgery, in terms of intraoperative opioid consumption and the quality of anesthetic emergence? It is hypothesized that to adjust the sevoflurane dose according to EEG targets in children undergoing surgeries where intraoperative antinociception cannot be provided via regional blocks will result in a reduction of sevoflurane requirements. However, a compensatory increase in intraoperative opioid consumption is expected to be observed, which could subsequently affect the quality and duration of the anesthetic recovery period.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Región
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Santiago, Región, Chile, 450881
- Hospital UC Christus
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 2-8 years
- ASA Physical Status I or II
- Elective tonsillectomy (±adenoidectomy)
- Signed parental consent (and assent ≥7 years)
Exclusion Criteria:
- Neurological or psychiatric disorders
- Growth or developmental delay
- Known allergy to study medications
- Coagulation disorders
- Parental or patient refusal
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Control Group
Induction with sevoflurane 5% in O₂.
Maintenance at fixed 1 age-adjusted MAC in O₂/air FiO₂ 60%.
BIS monitor attached but screen concealed; anesthesiologist blinded to EEG data.
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Arm Description: Induction with sevoflurane 5% in O₂.
Maintenance at fixed 1 age-adjusted MAC in O₂/air FiO₂ 60%.
BIS monitor attached but screen concealed; anesthesiologist blinded to EEG data.
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Experimental: Intervention Group
Induction with sevoflurane 3% in O₂.
Maintenance titrated to the minimum concentration sustaining a continuous slow-delta/alpha EEG pattern (SEF 17-20 Hz), starting at 0.7 age-adjusted MAC in O₂/air FiO₂ 60%.
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Induction with sevoflurane 3% in O₂.
Maintenance titrated to the minimum concentration sustaining a continuous slow-delta/alpha EEG pattern (SEF 17-20 Hz), starting at 0.7 age-adjusted MAC in O₂/air FiO₂ 60%.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total intraoperative opioid consumption
Prazo: Intraoperative period
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Mean fentanyl rate (mcg/kg).
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Intraoperative period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sevoflurane exposure
Prazo: Intraoperative period
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Age-adjusted MAC-hours
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Intraoperative period
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Sevoflurane exposure
Prazo: Intraoperative period
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EtSevo
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Intraoperative period
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EEG burst suppression
Prazo: Intraoperative period
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incidence
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Intraoperative period
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EEG spectral markers_TBP
Prazo: Intraoperative period
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Total band power
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Intraoperative period
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EEG spectral markers_MedF
Prazo: Intraoperative period
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Median frequency
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Intraoperative period
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EEG spectral markers_SEF95
Prazo: Intraoperative period
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SEF 95%
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Intraoperative period
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EEG burst suppression
Prazo: Intraoperative period
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Cumulative duration
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Intraoperative period
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hemodynamic, Bradicardia
Prazo: Intraoperative period
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Intraoperative bradycardia (HR<20% basaline) requiring intervention
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Intraoperative period
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hemodynamic, hypotension
Prazo: Intraoperative period
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intraoperative hypotension (MAP<20% basaline) requiring intervention
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Intraoperative period
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emergence time
Prazo: From end of anesthesia period to extubation
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Time from anesthesia discontinuation to extubation
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From end of anesthesia period to extubation
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Eye opening, emergence time
Prazo: From end of anesthesia period to extubation
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Time from anesthesia discontinuation to eye opening
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From end of anesthesia period to extubation
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emergence delirium
Prazo: Post anesthesia period
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incidence by paed scale
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Post anesthesia period
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Postoperative pain
Prazo: Post anesthesia period
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flacc/vas scores
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Post anesthesia period
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Rescue analgesia
Prazo: Post anesthesia period
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Drug use for rescue analgesia non opioids (mg)
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Post anesthesia period
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postoperative opioid use
Prazo: Post anesthesia period
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fentanyl use for pain rescue (mcg)
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Post anesthesia period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Victor Contreras, MSN, RN, Researcher
- Investigador principal: Mauricio Ibacache, Phd, Professor
Publicações e links úteis
Publicações Gerais
- Wang HY, Chen TY, Li DJ, Lin PY, Su KP, Chiang MH, Carvalho AF, Stubbs B, Tu YK, Wu YC, Roerecke M, Smith L, Tseng PT, Hung KC. Association of pharmacological prophylaxis with the risk of pediatric emergence delirium after sevoflurane anesthesia: An updated network meta-analysis. J Clin Anesth. 2021 Dec;75:110488. doi: 10.1016/j.jclinane.2021.110488. Epub 2021 Sep 1.
- Miyasaka KW, Suzuki Y, Brown EN, Nagasaka Y. EEG-Guided Titration of Sevoflurane and Pediatric Anesthesia Emergence Delirium: A Randomized Clinical Trial. JAMA Pediatr. 2025 Apr 21;179(7):704-12. doi: 10.1001/jamapediatrics.2025.0517. Online ahead of print.
- Sun Y, Ye F, Wang J, Ai P, Wei C, Wu A, Xie W. Electroencephalography-Guided Anesthetic Delivery for Preventing Postoperative Delirium in Adults: An Updated Meta-analysis. Anesth Analg. 2020 Sep;131(3):712-719. doi: 10.1213/ANE.0000000000004746.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Complicações pós-operatórias
- Processos Patológicos
- Confusão
- Manifestações Neurocomportamentais
- Distúrbios Neurocognitivos
- Delírio
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Delírio de emergência
- Dor, Pós-operatório
Outros números de identificação do estudo
- 260319004
Plano para dados de participantes individuais (IPD)
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