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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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Diyarbakır, Turecko (Türkiye), 21070
- SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Umbilical arterial pH
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maternal hypotension
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Apgar score at 1 minute
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD, Gazi Yaşargil Training and Research Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Metabolické choroby
- Acidobazická nerovnováha
- Nutriční a metabolické nemoci
- Acidóza
- Organické chemikálie
- Uhlovodíky
- Uhlovodíky, cyklické
- Uhlovodíky, aromatické
- Aminy
- Katecholy
- Fenoly
- Deriváty benzenu
- Alkoholy
- Propanolaminy
- Amino alkoholy
- Propanoly
- Ethanolaminy
- Fenylaminy
- Ethylaminy
- Biogenní monoaminy
- Biogenní aminy
- Katecholaminy
- Norepinefrin
- Efedrin
Další identifikační čísla studie
- GYEAH-OB-NE-EF-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
IPD will not be shared because data sharing was not included in the approved study protocol.
Informace o lécích a zařízeních, studijní dokumenty
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