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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Ankara, Turquia (Türkiye)
- Ankara Bilkent City Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Experimental: Opioid-Free High-Flow anesthesia
Patients receive opioid-free high-flow sevoflurane anesthesia during maintenance of general anesthesia combined with caudal block.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Emergence agitation assessed by Pediatric Anesthesia Emergence Delirium scale
Prazo: First 30 minutes in PACU
|
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.
|
First 30 minutes in PACU
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Emergence agitation assessed by Watcha scale
Prazo: First 30 minutes in the post-anesthesia care unit (PACU)
|
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.
|
First 30 minutes in the post-anesthesia care unit (PACU)
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- 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
Outros números de identificação do estudo
- E2-24-9001
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 .