Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery
Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing Cesarean Delivery
The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery.
The main questions it aims to answer are:
Does intravenous dexamethasone reduce the incidence of post-spinal hypotension?
Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)?
Does intravenous dexamethasone prolong the duration of postoperative analgesia?
Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief.
Participants will:
Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia.
Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery).
Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale).
Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Ho Chi Minh
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Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
- University Medical Center Ho Chi Minh City (UMC) - Campus 2
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- American Society of Anesthesiologists (ASA) physical status classification of II-III
- Planned for elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
- Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
- Gestational hypertension or chronic hypertension
- Body mass index (BMI) ≥ 35 kg/m²
- Known allergy to dexamethasone
- Current long-term corticosteroid therapy
- Diagnosis of postpartum hemorrhage
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
|
Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.
|
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Experimental: Dexametasona
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Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Post-Spinal Hypotension
Periodo de tiempo: From the induction of spinal anesthesia until the completion of surgery
|
The number of participants experiencing at least one episode of post-spinal hypotension.
Hypotension is defined as a decrease in systolic blood pressure of 20% or more from the baseline value.
Baseline blood pressure is defined as the mean value of three consecutive measurements taken 2 minutes apart, with a variation of less than 10%.
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are recorded every minute for the first 20 minutes after spinal anesthesia, and then every 5 minutes until the completion of surgery and transfer to the post-anesthesia care unit
|
From the induction of spinal anesthesia until the completion of surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting (PONV)
Periodo de tiempo: From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
|
The number of participants experiencing nausea, vomiting, or retching, or requiring rescue antiemetic treatment.
Rescue treatment is administered as intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg.
|
From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
|
|
Duration of Postoperative Analgesia
Periodo de tiempo: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
|
The time elapsed from the administration of spinal anesthesia to the patient's first request for systemic rescue analgesic medication.
Rescue analgesia is administered when the patient complains of pain and records a Visual Analog Scale (VAS) score greater than 4 (on a scale of 0 to 10).
|
From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Signos y Síntomas Digestivos
- Vómitos
- Náuseas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Náuseas y vómitos postoperatorios
- Compuestos policíclicos
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Esparrazadienetrioles
- Dexametasona
Otros números de identificación del estudio
- 4667/UMP-BOARD
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.
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