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Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery

25 de agosto de 2022 actualizado por: Maha Mostafa Ahmad, MD, Kasr El Aini Hospital

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

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

Intervencionista

Inscripción (Anticipado)

276

Fase

  • Fase 4

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.

Estudio Contacto

Ubicaciones de estudio

      • Cairo, Egipto, 11562
        • Reclutamiento
        • Kasr Alaini hospital
        • Contacto:

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

18 años a 40 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

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

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 0.03 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
epinephrine infusion rate of 0.03 mcg/kg/min
Otros nombres:
  • adrenalina
Comparador activo: 0.02 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
epinephrine infusion rate of 0.02 mcg/kg/min
Otros nombres:
  • adrenalina
Comparador activo: 0.01 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
epinephrine infusion rate of 0.01 mcg/kg/min
Otros nombres:
  • adrenalina

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
incidence of postspinal hypotension
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure ≤80% of the baseline reading
1 minute after subarachnoid injection till 5 minutes after baby delivery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
incidence of tachycardia
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
heart rate > 130% of baseline
1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of hypertension
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure >120% of baseline
1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of severe hypotension
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure ≤60% of the baseline reading
1 minute after subarachnoid injection till 5 minutes after baby delivery
mean heart rate
Periodo de tiempo: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
beat per minute
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mean systolic blood pressure
Periodo de tiempo: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mmHg
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
total ephedrine requirement
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mg
1 minute after subarachnoid injection till 5 minutes after baby delivery
total atropine requirement
Periodo de tiempo: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mg
1 minute after subarachnoid injection till 5 minutes after baby delivery
Apgar score
Periodo de tiempo: 5 minutes after delivery
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
5 minutes after delivery
umbilical blood pH
Periodo de tiempo: 5 minutes after delivery
pH
5 minutes after delivery
umbilical blood PCO2
Periodo de tiempo: 5 minutes after delivery
mmHg
5 minutes after delivery
umbilical blood PO2
Periodo de tiempo: 5 minutes after delivery
mmHg
5 minutes after delivery
umbilical blood HCO3
Periodo de tiempo: 5 minutes after delivery
mmol/L
5 minutes after delivery

Colaboradores e Investigadores

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

Patrocinador

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)

21 de marzo de 2022

Finalización primaria (Anticipado)

1 de agosto de 2022

Finalización del estudio (Anticipado)

1 de agosto de 2022

Fechas de registro del estudio

Enviado por primera vez

23 de febrero de 2022

Primero enviado que cumplió con los criterios de control de calidad

4 de marzo de 2022

Publicado por primera vez (Actual)

15 de marzo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2022

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

25 de agosto de 2022

Última verificación

1 de agosto de 2022

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

Available from PI upon reasonable request

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

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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