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- Ensayo clínico NCT05279703
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.
Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.
In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and the vasopressor infusion will be started.
- 0.01 mcg group
- 0.02 mcg group
- 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.
Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed Hasanin
- Número de teléfono: 01095076954
- Correo electrónico: ahmedmohamedhasanin@gmail.com
Ubicaciones de estudio
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Cairo, Egipto, 11562
- Reclutamiento
- Kasr Alaini hospital
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Contacto:
- Anesthesia, Pain Management and Surgical ICU Department
- Número de teléfono: 00201222224057
- Correo electrónico: Anesthesia.kasralainy@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- full-term singleton pregnant women
- American society of anesthesiologist-physical status I or II,
- scheduled for elective cesarean delivery
Exclusion Criteria:
- Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- hypertensive disorders of pregnancy,
- peripartum bleeding,
- coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or
- any contraindication to regional anesthesia,
- and baseline systolic blood pressure (SBP) < 100 mmHg
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 0.03 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
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epinephrine infusion rate of 0.03 mcg/kg/min
Otros nombres:
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Comparador activo: 0.02 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
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epinephrine infusion rate of 0.02 mcg/kg/min
Otros nombres:
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Comparador activo: 0.01 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
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epinephrine infusion rate of 0.01 mcg/kg/min
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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incidence of postspinal hypotension
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
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systolic blood pressure ≤80% of the baseline reading
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1 minute after subarachnoid injection till 5 minutes after baby delivery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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incidence of tachycardia
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
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heart rate > 130% of baseline
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1 minute after subarachnoid injection till 5 minutes after baby delivery
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incidence of hypertension
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
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systolic blood pressure >120% of baseline
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1 minute after subarachnoid injection till 5 minutes after baby delivery
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incidence of severe hypotension
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
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systolic blood pressure ≤60% of the baseline reading
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1 minute after subarachnoid injection till 5 minutes after baby delivery
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mean heart rate
Periodo de tiempo: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
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beat per minute
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1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
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mean systolic blood pressure
Periodo de tiempo: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
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mmHg
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1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
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total ephedrine requirement
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
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mg
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1 minute after subarachnoid injection till 5 minutes after baby delivery
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total atropine requirement
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
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mg
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1 minute after subarachnoid injection till 5 minutes after baby delivery
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Apgar score
Periodo de tiempo: 5 minutes after delivery
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Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
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5 minutes after delivery
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umbilical blood pH
Periodo de tiempo: 5 minutes after delivery
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pH
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5 minutes after delivery
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umbilical blood PCO2
Periodo de tiempo: 5 minutes after delivery
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mmHg
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5 minutes after delivery
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umbilical blood PO2
Periodo de tiempo: 5 minutes after delivery
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mmHg
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5 minutes after delivery
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umbilical blood HCO3
Periodo de tiempo: 5 minutes after delivery
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mmol/L
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5 minutes after delivery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Hipotensión
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Agonistas beta adrenérgicos
- Simpaticomiméticos
- Agentes vasoconstrictores
- Midriáticos
- Epinefrina
- Racepinefrina
- Borato de epinefrilo
Otros números de identificación del estudio
- MD-399-2021
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.
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