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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mhamed Sami Mebazaa, professor
- Número de teléfono: 00216 22252589
- Correo electrónico: msmebazaa@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Amani Ben Haj youssef, assistant
- Número de teléfono: 00216 96874336
- Correo electrónico: amani.benhajyoussef@fmt.utm.tn
Ubicaciones de estudio
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Tunis, Túnez, 2046
- Mongi Slim Hospital
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Contacto:
- Amani Ben Haj youssef
- Número de teléfono: 96874336
- Correo electrónico: amani.benhajyoussef@fmt.utm.tn
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Contacto:
- Correo electrónico: amani.benhajyoussef@fmt.utm.tn
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Investigador principal:
- Amani Ben Haj youssef, Assistant
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: 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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Incidence of pain during propofol injection
Periodo de tiempo: During induction of general anesthesia
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During induction of general anesthesia
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Intensity of pain during propofol injection
Periodo de tiempo: 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)
Periodo de tiempo: During the first 24 hours
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During the first 24 hours
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Patient satisfaction
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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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
- Propofol pain injection
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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