Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section

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.

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Key information

Conditions

Hypotenstion Anesthesia Spinal Cardiovascular Cesarean Resection Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adam Malik Hospital

Medan, North Sumatra, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norepinephrine 4mcg

Drug

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

Phenylephrine 50 mcg

Drug

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

Primary outcomes

Change in Systolic Blood Pressure (SBP) After Vasopressor Administration

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Official study title

Comparison of the Effectiveness of Bolus Doses of Norepinephrine 4 mcg and Phenylephrine 50 mcg in Managing Hypotension After Spinal Anesthesia in Cesarean Section Patients

Acronym: Norepinephrine

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Sep 4, 2025
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed