Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial
This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2.
Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This prospective, randomized, double-blind, controlled clinical trial aims to compare intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication is essential in pediatric anesthesia to reduce preoperative anxiety, facilitate parent-child separation, and improve cooperation during anesthesia induction. Oral midazolam is widely used but has limitations such as variable bioavailability and potential adverse behavioral effects. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has emerged as an alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
Eligible pediatric patients will be prospectively enrolled and randomly assigned to receive either intranasal dexmedetomidine or oral midazolam. A double-blind design will be maintained by administering both oral and intranasal preparations in each group. Premedication will be administered prior to anesthesia induction, and perioperative clinical parameters will be recorded.
This study is expected to provide clinically relevant evidence regarding the effectiveness and safety of intranasal dexmedetomidine compared to oral midazolam, potentially contributing to improved premedication strategies in pediatric anesthesia.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Siyament Cangir, M.D.
- Número de telefone: +905534411047
- E-mail: siyamentcangir@gmail.com
Estude backup de contato
- Nome: Fatma K Acil, M.D.
- Número de telefone: +905337225225
- E-mail: acilfatma@gmail.com
Locais de estudo
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Outside of the US
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Diyarbakır, Outside of the US, Turquia (Türkiye), 21070
- Recrutamento
- Siyament Cangir
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Contato:
- Fatma Acil, M.D.
- Número de telefone: +905337225225
- E-mail: acilfatma@gmail.com
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Contato:
- Siyament Cangir, M.D.
- Número de telefone: +905534411047
- E-mail: siyamentcangir@gmail.com
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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 inguinal or urological surgery under general anesthesia
- Both male and female patients
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Known allergy or hypersensitivity to dexmedetomidine or midazolam
- Presence of significant systemic disease or organ dysfunction
- Cardiac arrhythmia or congenital heart disease
- Neurological or behavioral disorders, including developmental delay
- Chronic use of analgesics or other medications that may affect study outcomes
- Anticipated difficult airway
- Nasal pathology that may interfere with intranasal drug administration
- Emergency surgery
- Inability to obtain written informed consent from parents or legal guardians
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Midazolam Group
Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding.
This approach ensures consistent administration routes across study groups.
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Oral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Outros nomes:
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Experimental: Dexmedetomidine Group
Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.
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Intranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Outros nomes:
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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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Proportion of patients achieving adequate sedation at anesthesia induction
Prazo: Approximately 30 minutes after premedication, at anesthesia induction
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Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction
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Approximately 30 minutes after premedication, at anesthesia induction
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Parent-child separation anxiety score
Prazo: At parent-child separation before anesthesia induction
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Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of >2 is defined as significant separation anxiety. Unit of Measure: Units on a scale |
At parent-child separation before anesthesia induction
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Mask acceptance at induction
Prazo: At the time of mask application during anesthesia induction
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Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction.
Mask Acceptance will be defined as WDS 1-2.
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At the time of mask application during anesthesia induction
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Postoperative emergence agitation
Prazo: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Emergence agitation will be assessed using the Watcha Behavior Scale (WDS).
Agitation will be defined as WDS >2.
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At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Need for rescue sedation
Prazo: From premedication until anesthesia induction
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Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
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From premedication until anesthesia induction
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PACU recovery time
Prazo: During PACU stay until discharge criteria are met
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Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.
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During PACU stay until discharge criteria are met
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Postoperative pain score
Prazo: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Postoperative pain will be assessed using the FLACC scale.
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At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Extubation time
Prazo: Intraoperative to immediate postoperative period
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Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
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Intraoperative to immediate postoperative period
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Mean Arterial Pressure (MAP)
Prazo: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
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Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period. Unit of Measure: mmHg |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
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Heart Rate (HR)
Prazo: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
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Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia. Unit of Measure: Beats per minute (bpm) |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
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Oxygen Saturation (SpO2)
Prazo: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
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SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status. Unit of Measure: Percentage (%) |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
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Colaboradores e Investigadores
Investigadores
- Diretor de estudo: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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
Palavras-chave
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
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Azoles
- Imidazoles
- Benzazepínicos
- Benzodiazepínicos
- Midazolam
- Dexmedetomidina
Outros números de identificação do estudo
- 27/01/2026-35
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
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