Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section

NCT ID: NCT07153601

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2025-05-10

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.

Conditions

Hypotenstion; Cesarean Resection; Anesthesia Spinal; Pregnancy Complications; Cardiovascular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Norepinephrine Group

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.

Group Type: EXPERIMENTAL

Norepinephrine 4mcg

Intervention Type: DRUG

Norepinephrine 4 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia.

Phenylephrine Group

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

Group Type: EXPERIMENTAL

Phenylephrine 50 mcg

Intervention Type: DRUG

Phenylephrine 50 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia.

Interventions

Norepinephrine 4mcg

Norepinephrine 4 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia.

Intervention Type: DRUG

Phenylephrine 50 mcg

Phenylephrine 50 mcg IV bolus diluted in 2 mL normal saline, administered upon onset of hypotension during spinal anesthesia.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitas Sumatera Utara

OTHER

Sponsor Role: lead

Responsible Party

Imam Syahputra

dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adam Malik Hospital

Medan, North Sumatra, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

103/KEPK/USU/2025

Identifier Type: -

Identifier Source: org_study_id