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- Ensayo clínico NCT07714785
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Región
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Santiago, Región, Chile, 450881
- Hospital UC Christus
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total intraoperative opioid consumption
Periodo de tiempo: Intraoperative period
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Mean fentanyl rate (mcg/kg).
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Intraoperative period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sevoflurane exposure
Periodo de tiempo: Intraoperative period
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Age-adjusted MAC-hours
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Intraoperative period
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Sevoflurane exposure
Periodo de tiempo: Intraoperative period
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EtSevo
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Intraoperative period
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EEG burst suppression
Periodo de tiempo: Intraoperative period
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incidence
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Intraoperative period
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EEG spectral markers_TBP
Periodo de tiempo: Intraoperative period
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Total band power
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Intraoperative period
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EEG spectral markers_MedF
Periodo de tiempo: Intraoperative period
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Median frequency
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Intraoperative period
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EEG spectral markers_SEF95
Periodo de tiempo: Intraoperative period
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SEF 95%
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Intraoperative period
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EEG burst suppression
Periodo de tiempo: Intraoperative period
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Cumulative duration
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Intraoperative period
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hemodynamic, Bradicardia
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Post anesthesia period
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incidence by paed scale
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Post anesthesia period
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Postoperative pain
Periodo de tiempo: Post anesthesia period
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flacc/vas scores
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Post anesthesia period
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Rescue analgesia
Periodo de tiempo: 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
Periodo de tiempo: 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
- Silla de estudio: Victor Contreras, MSN, RN, Researcher
- Investigador principal: Mauricio Ibacache, Phd, Professor
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Delirio
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Delirio de emergencia
- Dolor Postoperatorio
Otros números de identificación del estudio
- 260319004
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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