Ephedrine Versus Norepinephrine and Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia (NEO-FET)
Comparative Effects of Ephedrine and Norepinephrine on Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia: A Randomized Double-Blind Study
This study compares ephedrine and norepinephrine for the treatment of low blood pressure (hypotension) that may occur during cesarean delivery under spinal anesthesia. Maternal hypotension can reduce uteroplacental blood flow and may affect fetal well-being. Both medications are commonly used to restore blood pressure. The primary aim of this study is to compare their effects on neonatal acid-base status, assessed by umbilical arterial pH measured immediately after birth. Secondary outcomes include other umbilical arterial blood gas parameters, maternal blood pressure and heart rate, vasopressor requirements, maternal adverse events, and neonatal Apgar scores.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acid-base status during elective cesarean delivery under spinal anesthesia. Maternal hypotension is a common complication of spinal anesthesia and may reduce uteroplacental perfusion. Ephedrine and norepinephrine are both used to restore maternal blood pressure, but their comparative effects on fetal acid-base balance and maternal hemodynamics remain incompletely defined.
The primary aim of the study is to compare umbilical arterial pH between patients treated with ephedrine and those treated with norepinephrine for postspinal hypotension. Secondary outcomes include other umbilical arterial blood gas parameters, including pCO₂, bicarbonate, base excess, and lactate; the incidence of neonatal acidosis defined as umbilical arterial pH <7.20; Apgar scores at 1 and 5 minutes; maternal systolic blood pressure and heart rate; vasopressor requirements; and maternal adverse events.
A total of 155 parturients were randomized in a 1:1 ratio before spinal anesthesia. Because the study drugs were administered only when postspinal hypotension occurred, the analysis population consisted of randomized participants who developed hypotension and received the allocated vasopressor. This resulted in 102 participants in the final analysis population, including 50 in the ephedrine group and 52 in the norepinephrine group.
All randomized participants underwent a standardized spinal anesthesia protocol. Postspinal hypotension was treated with repeated intravenous boluses of either ephedrine 5 mg or norepinephrine 5 µg according to the allocated treatment arm. The study was designed to compare fetal acid-base effects and maternal hemodynamic responses associated with these two vasopressor strategies.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Diyarbakır, Turquía (Türkiye), 21070
- SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
nclusion Criteria:
- Women aged 18-45 years
- Singleton term pregnancy (≥37 weeks of gestation)
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
- Hypertensive disorders of pregnancy
- Known systemic disease
- Multiple gestation
- Emergency cesarean delivery
- Contraindication to spinal anesthesia
- Known allergy to the study medications
- Pre-diagnosed fetal growth restriction identified using standardized growth curves and pathological Doppler findings
- Suspected fetal distress
- Oligohydramnios
- Known congenital fetal anomalies
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Ephedrine Group
Participants allocated to this group received intravenous ephedrine 5 mg boluses for the treatment of postspinal hypotension. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. |
Intravenous ephedrine 5 mg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.
Otros nombres:
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Experimental: Norepinephrine Group
Participants allocated to this group received intravenous norepinephrine 5 µg boluses for the treatment of postspinal hypotension. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. |
Intravenous norepinephrine 5 µg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.
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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Umbilical arterial pH
Periodo de tiempo: Immediately after delivery
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Umbilical arterial pH measured immediately after delivery from an arterial blood sample obtained from a double-clamped segment of the umbilical cord and analyzed within 5 minutes using a blood gas analyzer. |
Immediately after delivery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maternal hypotension
Periodo de tiempo: From spinal anesthesia until delivery
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Postspinal hypotension was defined as a decrease in systolic blood pressure to less than 80% of the baseline value. The number and duration of hypotensive episodes were recorded. |
From spinal anesthesia until delivery
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Incidence of neonatal acidosis (UA pH <7.20)
Periodo de tiempo: Immediately after delivery
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Incidence of neonatal acidosis, defined as an umbilical arterial pH <7.20, determined from an umbilical arterial blood sample obtained immediately after delivery and analyzed using a point-of-care blood gas analyzer. |
Immediately after delivery
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Maternal heart rate response
Periodo de tiempo: From spinal anesthesia until delivery / during surger
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Maternal heart rate was recorded after spinal anesthesia and during periods requiring vasopressor administration. Temporal heart rate changes and the occurrence of tachycardia were recorded. |
From spinal anesthesia until delivery / during surger
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Apgar score at 1 minute
Periodo de tiempo: At 1 minute after delivery
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Apgar Score (Appearance, Pulse, Grimace, Activity, Respiration) will be assessed by the attending neonatologist. The score ranges from 0 to 10, where higher scores indicate better neonatal condition. The outcome is the distribution of Apgar scores at 1 minute after birth. |
At 1 minute after delivery
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Apgar score at 5 minutes
Periodo de tiempo: At 5 minutes after delivery
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Apgar Score (Appearance, Pulse, Grimace, Activity, Respiration) will be assessed by the attending neonatologist. The score ranges from 0 to 10, where higher scores indicate better neonatal condition. The outcome is the distribution of Apgar scores at 5 minutes after birth. |
At 5 minutes after delivery
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Requirement for additional vasopressor doses
Periodo de tiempo: During surgery
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The number of vasopressor boluses and the total amount of ephedrine (mg) or norepinephrine (µg) administered for treatment of postspinal hypotension were recorded. |
During surgery
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Neonatal heart rate after delivery
Periodo de tiempo: Immediately after delivery
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Neonatal heart rate measured after delivery and compared between the ephedrine and norepinephrine groups. |
Immediately after delivery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD, Gazi Yaşargil Training and Research Hospital
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Desequilibrio ácido-base
- Enfermedades Nutricionales y Metabólicas
- Acidosis
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Amina
- Catecols
- Fenoles
- Derivados de benceno
- Alcoholes
- Propanolaminas
- Amino alcoholes
- Propanols
- Etanolaminas
- Fenetilaminas
- Etilaminas
- Monoaminas biogénicas
- Aminas biogénicas
- Catecolaminas
- Noradrenalina
- Efedrina
Otros números de identificación del estudio
- GYEAH-OB-NE-EF-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
IPD will not be shared because data sharing was not included in the approved study protocol.
Información sobre medicamentos y dispositivos, documentos del estudio
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