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THIS STUDY AIMS TO COMPARE TWO DRUGS KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING SPINAL ANESTHESIA STUDY POPULATION IS PT UNDERGOING C SECTION . DOSE OF KETAMINE IS 0.25mg/kg and That of TRAMAL 0.5mg/kg.

20 de agosto de 2026 actualizado por: Hibba Asif, KRL Hospital, Islamabad

COMPARISON BETWEEN KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING C SECTION UNDER SPINAL ANESTHESIA

This randomized controlled clinical trial compared the efficacy of intravenous ketamine and tramadol in preventing post-spinal anaesthesia shivering among women undergoing elective caesarean section under spinal anaesthesia. Seventy pregnant women aged 18-45 years with ASA physical status II or III were enrolled and randomly assigned to receive either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) immediately after delivery of the baby. The primary outcome was the prevention of shivering, defined as the absence of shivering throughout the intraoperative period using the bedside shivering assessment score. Secondary outcomes included the onset time of shivering and comparison of efficacy according to age, body mass index (BMI), and ASA physical status. The study found that ketamine was significantly more effective than tramadol in preventing post-spinal anaesthesia shivering in women undergoing caesarean section, with a lower incidence of shivering and higher overall efficacy. These findings suggest that prophylactic low-dose ketamine may be a more effective option than tramadol for reducing spinal anaesthesia-related shivering during caesarean delivery

Descripción general del estudio

Estado

Terminado

Descripción detallada

This randomized controlled clinical trial was conducted at Khan Research Laboratory Hospital, Islamabad, from August 2024 to January 2025 after obtaining ethical approval. The objective was to compare the efficacy of intravenous ketamine and intravenous tramadol in preventing shivering among women undergoing elective caesarean section under spinal anaesthesia.

A total of 70 pregnant women aged between 18 and 45 years with ASA physical status II or III and a body mass index between 18 and 35 kg/m² were included after obtaining written informed consent. Patients with contraindications to spinal anaesthesia, significant medical comorbidities, allergy to study drugs, obstetric emergencies, pre-existing bradycardia, hypotension, or refusal to undergo spinal anaesthesia were excluded.

Participants were randomly allocated into two equal groups using a coin-flip randomization method. Standard perioperative preparation and monitoring were performed for all patients. Spinal anaesthesia was administered using hyperbaric bupivacaine through a standard spinal technique. Immediately after delivery of the baby, patients received either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) according to their assigned study group.

Patients were monitored throughout surgery for the occurrence of shivering using the bedside shivering assessment score. The primary endpoint was efficacy, defined as complete absence of shivering until completion of surgery and wound closure. Secondary outcome measures included the incidence of shivering, onset time of shivering after spinal anaesthesia, and subgroup analyses according to age, BMI, and ASA physical status.

Data were analysed using SPSS version 30. Quantitative variables were summarized using median and interquartile range because data were not normally distributed. Qualitative variables were expressed as frequencies and percentages. Group comparisons were performed using the Chi-square test, Fisher's exact test, and Mann-Whitney U test where appropriate. A p-value of ≤0.05 was considered statistically significant.

The baseline demographic characteristics were comparable between the two groups with respect to age, BMI, and ASA status. The incidence of post-spinal anaesthesia shivering was significantly lower in the ketamine group than in the tramadol group. Patients receiving ketamine demonstrated a substantially higher proportion of successful prevention of shivering compared with those receiving tramadol. Furthermore, the onset of shivering was delayed or absent in most patients receiving ketamine. Stratified analyses according to age, BMI, and ASA classification did not demonstrate any significant influence of these variables on treatment efficacy.

The study findings indicate that prophylactic low-dose intravenous ketamine provides superior protection against post-spinal anaesthesia shivering compared with low-dose intravenous tramadol in women undergoing caesarean section under spinal anaesthesia. These results support the use of ketamine as an effective prophylactic agent for reducing intraoperative shivering in obstetric patients and may contribute to improved maternal comfort.

Tipo de estudio

Intervencionista

Inscripción (Actual)

70

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Islamabad
      • Islamabad, Islamabad, Pakistán, 44000
        • KRL Hospital Islamabad
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistán, 46000
        • KRL Hospital Islamabad

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

ASA-2 and ASA-3 patients Undergoing Elective C-Section

Exclusion Criteria:

ASA-4 and above Emergency C-Section Cases

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Tramadol Group
Participants received intravenous tramadol 0.5 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.
Single IV dose of tramadol 0.5 mg/kg given immediately after delivery.
Experimental: Ketamine Group
Participants received intravenous ketamine 0.25 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.
Single intravenous dose of ketamine 0.25 mg/kg administered immediately after delivery of the baby during elective caesarean section under spinal anaesthesia for prevention of post-spinal shivering.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Post-Spinal Anesthesia Shivering
Periodo de tiempo: Within 30 minutes of spinal anesthesia administration
Proportion of patients who developed shivering after spinal anesthesia, graded using the Tsai and Chu shivering scale (0 = no shivering; 1 = piloerection; 2 = visible tremors in one muscle group; 3 = visible tremors in more than one muscle group; 4 = gross tremors of the whole body).
Within 30 minutes of spinal anesthesia administration

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Severity of Post-Spinal Anesthesia Shivering
Periodo de tiempo: Within 30 minutes of spinal anesthesia administration
Severity of shivering graded using the Tsai and Chu scale (0-4) in patients who developed shivering after spinal anesthesia.
Within 30 minutes of spinal anesthesia administration

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Amna Raza, MBBS FCPS, KRL Hospital, Islamabad

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de julio de 2024

Finalización primaria (Actual)

20 de agosto de 2025

Finalización del estudio (Actual)

21 de septiembre de 2025

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de agosto de 2026

Publicado por primera vez (Actual)

25 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared publicly.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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