Minimal- Versus High-Flow Sevoflurane and Emergence Agitation in Pediatric Surgery
Comparison of the Effects of Minimal-Flow and High-Flow Sevoflurane on Emergence Agitation in Opioid-Free Pediatric Surgeries During General Anesthesia Maintenance
This study aims to evaluate the effects of minimal-flow sevoflurane compared with high-flow sevoflurane during maintenance of general anesthesia on postoperative emergence agitation in opioid-free pediatric infraumbilical surgeries. Patients will be randomly assigned to receive either opioid-free minimal-flow anesthesia combined with caudal block or opioid-free high-flow anesthesia combined with caudal block.
The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale and the Watcha scale. Secondary outcomes include the incidence of postoperative nausea and vomiting and recovery characteristics. In addition, all patients will be followed up via telephone at 3 months postoperatively to assess the presence of persistent chronic or neuropathic pain at the surgical site.
The findings of this study may contribute to optimizing anesthesia strategies and improving postoperative outcomes in pediatric patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Emergence agitation (EA) is a common and clinically significant complication in pediatric patients following general anesthesia, particularly after the use of volatile anesthetic agents such as sevoflurane. The etiology of EA is multifactorial and may be associated with rapid emergence, postoperative pain, preoperative anxiety, and the use of opioids. Strategies aimed at reducing opioid consumption and optimizing anesthetic techniques may help improve postoperative recovery profiles in children.
Opioid-free anesthesia (OFA) has gained increasing attention as a multimodal approach that minimizes or eliminates intraoperative opioid use while maintaining adequate analgesia and hemodynamic stability. In addition, low-flow anesthesia techniques may contribute to improved respiratory conditions, better humidification, and more stable anesthetic depth, which could potentially influence emergence characteristics. However, the combined effect of opioid-free and low-flow anesthesia on emergence agitation in pediatric populations has not been sufficiently investigated.
In this prospective, randomized, single-blind study, pediatric patients undergoing infraumbilical surgery will be allocated to receive either opioid-free minimal-flow anesthesia combined with caudal epidural block or conventional anesthesia management. Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale as the primary outcome, and the Watcha scale as a secondary assessment tool. Additional outcomes include postoperative pain scores, incidence of postoperative nausea and vomiting (PONV), and recovery parameters. This study aims to provide evidence on whether opioid-free minimal-flow anesthesia can improve postoperative behavioral outcomes and enhance recovery quality in pediatric patients.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Ankara Bilkent City Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pediatric patients aged 2-10 years
- ASA physical status I-II
- Scheduled for elective infraumbilical surgery
- Planned to receive general anesthesia with caudal block
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- - Refusal of parental consent
- Known allergy to study drugs
- Neurological or developmental disorders
- Psychiatric disorders or use of psychoactive medications
- Chronic pain or regular analgesic use
- Contraindication to caudal block (infection at site, coagulopathy, anatomical abnormality)
- Significant cardiovascular, respiratory, hepatic, or renal disease
- Emergency surgery
- Signs of failed caudal epidural block, defined as a greater than 20% increase in heart rate or blood pressure in response to surgical stimulation, an increase in bispectral index (BIS) values, or the requirement for additional intravenous anesthetic agents.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: opioid-free minimal-flow anesthesia
In this arm, pediatric patients undergoing infraumbilical surgery under opioid-free general anesthesia receive a caudal epidural block after tracheal intubation.
Anesthesia is then maintained with minimal-flow sevoflurane.
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In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.
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Experimental: Opioid-Free High-Flow anesthesia
Patients receive opioid-free high-flow sevoflurane anesthesia during maintenance of general anesthesia combined with caudal block.
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In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Emergence agitation assessed by Pediatric Anesthesia Emergence Delirium scale
Periodo de tiempo: First 30 minutes in PACU
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Pediatric Anesthesia Emergence Delirium (PAED) Scale score ranging from 0 to 20 points.
Higher scores indicate more severe emergence delirium.
Emergence delirium will be defined as a PAED score ≥10.
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First 30 minutes in PACU
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emergence agitation assessed by Watcha scale
Periodo de tiempo: First 30 minutes in the post-anesthesia care unit (PACU)
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Emergence agitation will be assessed using the Watcha scale (1-4 points), with higher scores indicating more severe agitation.
Patients with a Watcha score ≥3 will be classified as having emergence agitation.
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First 30 minutes in the post-anesthesia care unit (PACU)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Hendren WH. From an acorn to an oak. J Pediatr Surg. 1999 May;34(5 Suppl 1):46-58. doi: 10.1016/s0022-3468(99)90830-8. No abstract available.
- Levy JH, Dutton RP, Hemphill JC 3rd, Shander A, Cooper D, Paidas MJ, Kessler CM, Holcomb JB, Lawson JH; Hemostasis Summit Participants. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010 Feb 1;110(2):354-64. doi: 10.1213/ANE.0b013e3181c84ba5. Epub 2009 Dec 10.
- Enooku K, Kato R, Ikeda H, Kurano M, Kume Y, Yoshida H, Ono T, Aizawa K, Suzuki T, Yamazaki T, Yatomi Y. Inverse correlations between serum ADAMTS13 levels and systolic blood pressure, pulse pressure, and serum C-reactive protein levels observed at a general health examination in a Japanese population: a cross-sectional study. Clin Chim Acta. 2013 Jun 5;421:147-51. doi: 10.1016/j.cca.2013.03.012. Epub 2013 Mar 21.
- Kopterides P, Kapetanakis T, Siempos II, Magkou C, Pelekanou A, Tsaganos T, Giamarellos-Bourboulis E, Roussos C, Armaganidis A. Short-term administration of a high oxygen concentration is not injurious in an ex-vivo rabbit model of ventilator-induced lung injury. Anesth Analg. 2009 Feb;108(2):556-64. doi: 10.1213/ane.0b013e31818f10f7.
- Ryalino C, Senapathi TGD, Pradhana AP, Yudikusumo A. Low-flow anesthesia technique reduces emergence agitation in pediatric patients underwent general anesthesia. Asian J Pharm Clin Res. 2019;12(5):139-141. doi:10.22159/ajpcr.2019.v12i5.32508
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E2-24-9001
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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