Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.
Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection: a Randomized Controlled Trial.
This is a prospective, single-center, randomized, double-blind controlled trial involving patients scheduled for elective surgery requiring general anesthesia with propofol induction. Participants are randomly assigned to one of three groups: the ondansetron group (8 mg IV), the lidocaine group (40 mg IV), or the control group (0.9% normal saline placebo). Study medications are administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
the goal: To assess the efficacy of intravenous ondansetron versus lidocaine and placebo in reducing the incidence and intensity of pain associated with propofol injection in patients undergoing general anesthesia.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This prospective, single-center, randomized, double-blind controlled trial is conducted at the operating theaters of the Mongi Slim University Hospital (Tunisia). The study aime to compare the effectiveness of intravenous ondansetron and lidocaine versus placebo in preventing pain associated with propofol injection during induction of general anesthesia.
Adult patients (ASA I-III) scheduled for elective surgery requiring propofol-based induction are randomly allocated in a 1:1:1 ratio to receive either ondansetron 8 mg, lidocaine 40 mg, or normal saline placebo before anesthesia induction. The primary outcome is the incidence of pain during propofol injection, while secondary outcomes include pain intensity, postoperative nausea and vomiting, patient satisfaction, and pain recall.
A total of 156 patients are planned for inclusion. Pain is assessed immediately after administration of an initial propofol bolus using a numerical rating scale (0-10) by a blinded observer. The study is designed to determine whether ondansetron could provide analgesic efficacy comparable to the current standard treatment, lidocaine, while also offering potential benefits related to the prevention of postoperative nausea and vomiting.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mhamed Sami Mebazaa, professor
- Número de telefone: 00216 22252589
- E-mail: msmebazaa@gmail.com
Estude backup de contato
- Nome: Amani Ben Haj youssef, assistant
- Número de telefone: 00216 96874336
- E-mail: amani.benhajyoussef@fmt.utm.tn
Locais de estudo
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Tunis, Tunísia, 2046
- Mongi Slim Hospital
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Contato:
- Amani Ben Haj youssef
- Número de telefone: 96874336
- E-mail: amani.benhajyoussef@fmt.utm.tn
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Contato:
- E-mail: amani.benhajyoussef@fmt.utm.tn
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Investigador principal:
- Amani Ben Haj youssef, Assistant
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- The study included patients who met all of the following criteria:
Aged 18 years or older; Classified as ASA physical status I-III (Appendix 1); Provided written informed consent to participate in the study; Scheduled for elective surgery requiring general anesthesia with propofol induction.
Exclusion Criteria:
- Patients were not eligible for inclusion if they:
Had received analgesics or antiemetics within 12 hours before surgery; Had communication difficulties or were unable to assess pain adequately (e.g., language barrier, dementia, impaired consciousness); Had a known allergy to ondansetron, lidocaine, or propofol; Did not receive propofol for anesthetic induction; Were pregnant or breastfeeding; Suffered from chronic pain or regularly used opioid medications; Did not have a 20-gauge intravenous catheter inserted on the dorsum of the hand; Declined participation in the study.
Patients were excluded from the study if they experienced any complication during anesthetic induction, including:
Anaphylactic shock or allergic reaction to study medications; Hemodynamic or respiratory instability.
Patients who subsequently withdrew their consent were also excluded from the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Group C (Control):
Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline
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Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline (placebo) administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
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Experimental: Group O (Ondansetron)
Group O (Ondansetron): Patients receive 8 mg of ondansetron
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Patients received 8 mg of ondansetron diluted to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
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Comparador Ativo: Group L (Lidocaine)
Group L (Lidocaine): Patients received 40 mg of lidocaine
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Patients received 40 mg of lidocaine diluted with 0.9% normal saline to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Incidence of pain during propofol injection
Prazo: During induction of general anesthesia
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During induction of general anesthesia
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Intensity of pain during propofol injection
Prazo: during the induction
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Intensity of pain during propofol injection, assessed using a Numerical Rating Scale (NRS) from 0 to 10: 0: No pain 1-3: Mild pain, or pain reported only in response to questioning 4-6: Moderate pain, or pain reported spontaneously without facial grimacing 7-10: Severe pain, characterized by marked vocal expression, facial grimacing, arm withdrawal, or tears |
during the induction
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Incidence of postoperative nausea and vomiting (PONV)
Prazo: During the first 24 hours
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During the first 24 hours
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Patient satisfaction
Prazo: Two hours after surgery
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Patient satisfaction, assessed using a Likert scale;
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Two hours after surgery
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Pain recall
Prazo: two hours after surgery
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Pain recall, evaluated by assessing patients' memory of the injection-related pain.
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two hours after surgery
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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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Propofol pain injection
Plano para dados de participantes individuais (IPD)
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