drugset / Trial / NCT07153601

Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section

NCT07153601

Completed 46 enrolled Universitas Sumatera Utara
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Spinal anesthesia is commonly used during C-sections but can cause a drop in the mother's blood pressure, which may affect both the mother and the baby. In this study, 46 pregnant women undergoing elective C-sections were randomly given either norepinephrine (4 mcg) or phenylephrine (50 mcg) when their blood pressure dropped. Researchers monitored their heart rate, blood pressure, and any side effects for 30 minutes after anesthesia. The results showed that both drugs were effective in raising blood pressure. However, norepinephrine kept the heart rate more stable, while phenylephrine caused a noticeable slowing of the heart rate (bradycardia). Both drugs were safe and well tolerated. This study suggests that norepinephrine may be a better option for managing low blood pressure during spinal anesthesia in C-sections, especially when maintaining heart rate and cardiac output is important.

Timeline

Start
2025-02-07
Primary completion
2025-05-10
Completion
2025-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Norepinephrine Other / unclassified 4 ug Intravenous
Subject Phenylephrine Small molecule 50 ug Intravenous