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临床试验/NCT06921473
NCT06921473已完成4 期

Effect of Ephedrine and Norepinephrine on Fetal Acidosis During Cesarean Section Under Spinal Anesthesia: A Prospective, Randomized Controlled Trial

mehmet özkılıç1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Incidence of fetal acidosis (umbilical artery pH < 7.20)

研究概览

简要总结

This study compares the effects of two medications, ephedrine and norepinephrine, on the baby (fetus) when used to treat low blood pressure (hypotension) during cesarean section under spinal anesthesia. Hypotension is a common side effect during spinal anesthesia, and it can affect the blood flow to the baby. Both medications are commonly used to manage this condition. The goal of the study is to determine which medication is more effective and safer for the baby, by measuring the pH level in the umbilical artery after birth. The study will also examine maternal blood pressure, heart rate, and the baby's Apgar scores.

详细描述

This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acidosis during cesarean section performed under spinal anesthesia. Maternal hypotension is a frequent complication associated with spinal anesthesia, and the management of this condition is critical for maintaining adequate uteroplacental perfusion. While both ephedrine and norepinephrine are commonly used vasopressors, there is ongoing debate regarding their relative safety and efficacy, particularly in terms of fetal outcomes.

The primary aim of this study is to evaluate the incidence of fetal acidosis, defined as an umbilical artery pH < 7.20, in patients receiving either ephedrine or norepinephrine. Secondary outcomes include maternal blood pressure control, heart rate, incidence of maternal and fetal tachycardia, Apgar scores at 1 and 5 minutes, and the need for additional vasopressor support. A total of 100 pregnant women undergoing elective cesarean section will be enrolled, with 50 participants in each treatment group. All participants will receive standardized spinal anesthesia, and vasopressors will be titrated according to protocol.

The study is designed to inform clinical decision-making regarding optimal vasopressor selection in obstetric anesthesia, with a focus on balancing maternal hemodynamic stability and fetal well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

No other parties are masked in this study.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged between 18 and 45 years
  • Singleton pregnancy at ≥ 37 weeks of gestation
  • Scheduled for elective cesarean section under spinal anesthesia
  • ASA (American Society of Anesthesiologists) physical status classification I or II
  • Ability to understand and sign the informed consent form

排除标准

  • History of allergy or hypersensitivity to ephedrine or norepinephrine
  • Multiple gestation pregnancies
  • Diagnosis of pre-eclampsia, eclampsia, or other hypertensive disorders of pregnancy
  • Known cardiovascular disease or arrhythmia
  • Placental abnormalities (e.g., placenta previa, placental abruption)
  • Fetal structural or chromosomal anomalies
  • Morbid obesity (BMI > 40 kg/m²)
  • Refusal to participate or inability to provide informed consent

研究组 & 干预措施

Ephedrine Group

Active Comparator

Participants in this group will receive intravenous bolus doses of ephedrine (5-10 mg) to manage spinal anesthesia-induced hypotension during cesarean section.

干预措施: Ephedrine (Drug)

Norepinephrine Group

Experimental

Participants in this group will receive intravenous bolus doses of norepinephrine (5-10 µg) to manage spinal anesthesia-induced hypotension during cesarean section.

干预措施: Norepinephrine (Drug)

结局指标

主要结局

Incidence of fetal acidosis (umbilical artery pH < 7.20)

时间窗: Within 5 minutes after birth

Fetal acidosis is defined as an umbilical artery blood pH \< 7.20. Arterial blood will be collected from a double-clamped segment of the umbilical cord immediately after delivery and analyzed using a validated blood gas analyzer.

次要结局

  • Incidence of maternal hypotension(Within 30 minutes post-spinal anesthesia)
  • Incidence of maternal tachycardia(During surgery)

研究者

发起方
mehmet özkılıç
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mehmet özkılıç

Specialist Doctor in Anesthesiology and Reanimation

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

研究点 (1)

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