- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07784556
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.
COMPARISON BETWEEN KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING C SECTION UNDER SPINAL ANESTHESIA
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Islamabad
-
Islamabad, Islamabad, Pakistán, 44000
- KRL Hospital Islamabad
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistán, 46000
- KRL Hospital Islamabad
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
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
¿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
Patrocinador
Investigadores
- Silla de estudio: Amna Raza, MBBS FCPS, KRL Hospital, Islamabad
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Compbketandtramal123
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .