Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia: Randomized Controlled Trial
Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical monitoring. While intravenous meperidine remains a widely used pharmacological agent for shivering prophylaxis, it carries dose-dependent adverse effects such as nausea, vomiting, sedation, and potential neonatal depression. Intranasal dexmedetomidine provides an alternative needle-free method of administration that rapidly absorbs through the nasal mucosa and reduces shivering without suppressing respiratory drive.
The primary purpose of this randomized controlled trial is to evaluate the efficacy of preoperative intranasal dexmedetomidine in reducing the incidence of intraoperative shivering compared with intravenous meperidine and placebo in women undergoing elective cesarean section under spinal anesthesia.
A total of 99 parturients will be randomly allocated to one of three parallel groups (33 patients per group) using a double-dummy design:
- Group D: Receives intranasal dexmedetomidine (1 mcg/kg) 30 minutes before spinal anesthesia, plus an intravenous saline placebo at spinal induction.
- Group M: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous meperidine (0.5 mg/kg) at spinal induction.
- Group C: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous saline placebo at spinal induction.
Participants will be monitored throughout the surgical procedure to determine the occurrence of shivering, maternal hemodynamic parameters (heart rate, blood pressure, oxygen saturation), sedation levels using the Richmond Agitation-Sedation Scale (RASS), need for rescue anti-shivering medication, side effects, and neonatal outcomes (Apgar scores and birth weight).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female patients aged 18 to 40 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Term singleton pregnancy.
- Scheduled for elective cesarean section under spinal anesthesia.
Exclusion Criteria:
- Refusal to participate.
- Contraindications to spinal anesthesia.
- Nasal pathology preventing intranasal drug administration.
- Known allergy or hypersensitivity to any study medication (dexmedetomidine, meperidine, or bupivacaine).
- Significant cardiac disease.
- Renal or hepatic impairment.
- Preeclampsia, eclampsia, or HELLP syndrome.
- Cesarean section requiring general anesthesia.
- Body mass index (BMI) > 40 kg/m².
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group D: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 1 mcg/kg diluted in 2 mL normal saline administered 30 minutes before induction of spinal anesthesia in the pre-anesthesia room, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (double-dummy placebo) (n = 33). |
Administered intranasally at a dose of 1 mcg/kg diluted in 2 mL normal saline 0.9% using a sterile dropper, instilled slowly into each nostril 30 minutes before induction of spinal anesthesia in the pre-anesthesia room. Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). |
|
Comparador Ativo: Group M: Intravenous Meperidine
Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia (double-dummy placebo), along with an intravenous bolus of meperidine 0.5 mg/kg diluted to 10 mL normal saline immediately before spinal injection (n = 33). |
Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). Administered as an intravenous bolus at a dose of 0.5 mg/kg diluted to a total volume of 10 mL normal saline 0.9% immediately before the induction of spinal anesthesia. |
|
Comparador de Placebo: Group C: Placebo Control
Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (n = 33). |
Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Intraoperative Shivering
Prazo: Through completion of surgery, up to 2 hours
|
Participants will be assessed for the occurrence of intraoperative shivering using a 5-point scale: Grade 0 = no shivering; Grade 1 = piloerection, peripheral vasoconstriction, or cyanosis; Grade 2 = visible muscle activity confined to one muscle group; Grade 3 = visible muscle activity involving more than one muscle group; Grade 4 = gross muscle activity involving the whole body (scores range from 0 to 4, where 0 indicates no shivering and 4 indicates severe whole-body shivering). Shivering is defined as the occurrence of Grade 1 or higher at any time during the procedure. |
Through completion of surgery, up to 2 hours
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- Mudanças de temperatura corporal
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Hipotermia
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Preparações farmacêuticas
- Azoles
- Imidazoles
- Piperidinas
- Soluções cristalóides
- Soluções isotônicas
- Soluções
- Ácidos, heterocíclicos
- Ácidos isonipecóticos
- Dexmedetomidina
- Meperidina
- Solução salina
Outros números de identificação do estudo
- Nasal Dex for Shivering in CS
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