Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section

Not Applicable

Completed

• Conditions: Hypotenstion; Cesarean Resection; Anesthesia Spinal; Cardiovascular; Pregnancy Complications
• Interventions: Drug: Norepinephrine 4mcg; Drug: Phenylephrine 50 mcg

• Registration Number: NCT07153601
• Lead Sponsor: Universitas Sumatera Utara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-07
• Primary Completion: 2025-05-10
• Study Completion: 2025-05-10
• Study First Submitted: 2025-07-08
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Female patients aged 18-40 years
• Undergoing elective cesarean section
• Receiving spinal anesthesia
• Classified as ASA Physical Status II
• Stable baseline hemodynamics prior to anesthesia
• Not using inotropic, chronotropic, or vasoactive drugs before surgery

Exclusion Criteria

• Emergency cesarean section
• Fetal distress
• Preeclampsia or eclampsia
• Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site)
• Known allergy to norepinephrine or phenylephrine
• Hemodynamic instability prior to vasopressor administration
• Withdrawal from study or refusal to participate
• Failure to develop post-spinal hypotension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norepinephrine Group	Norepinephrine 4mcg	Participants in this group received intravenous bolus doses of norepinephrine 4 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section.
Phenylephrine Group	Phenylephrine 50 mcg	Participants in this group received intravenous bolus doses of phenylephrine 50 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP) After Vasopressor Administration	Baseline to 2 minutes post-administration (T0-T2)	Change in systolic blood pressure measured before vasopressor administration (T0-T1) and two minutes after administration (T2) in response to intravenous bolus of norepinephrine 4 mcg or phenylephrine 50 mcg during spinal anesthesia-induced hypotension in cesarean section patients.

Trial Locations

Locations (1)

Adam Malik Hospital; 🇮🇩 Medan, North Sumatra, Indonesia