Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia

NCT06921473 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-12-29

No results posted yet for this study

Summary

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.

Conditions

  • Cesarean Delivery Affecting Newborn
  • Acidosis
  • Maternal Hypotension
  • Spinal Aneshtesia

Interventions

DRUG

Norepinephrine

Intravenous bolus of norepinephrine (5-10 µg) to treat spinal anesthesia-induced hypotension during cesarean section.

DRUG

Ephedrine

Intravenous bolus of 5-10 mg ephedrine administered as needed to treat maternal hypotension following spinal anesthesia during elective cesarean section. The drug is prepared in identical, unlabeled syringes to ensure blinding.

Sponsors & Collaborators

  • mehmet özkılıç

    lead OTHER

Principal Investigators

  • Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD · Gazi Yaşargil Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-12
Completion
2025-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921473 on ClinicalTrials.gov