Norepinephrine vs. Phenylephrine for Spinal Hypotension in Cesarean Section

NCT07153601 | Completed DMC

• 1 other identifier: 103/KEPK/USU/2025
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP) After Vasopressor Administration

  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.

  Baseline to 2 minutes post-administration (T0-T2)

Study Arms (2)

Norepinephrine Group

EXPERIMENTAL

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.

Drug: Norepinephrine 4mcg

Phenylephrine Group

EXPERIMENTAL

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

Drug: Phenylephrine 50 mcg

Interventions

Norepinephrine 4mcg DRUG

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

Norepinephrine Group

Phenylephrine 50 mcg DRUG

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

Phenylephrine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Adam Malik Hospital

Medan, North Sumatra, Indonesia

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: September 4, 2025
• Study Start: February 7, 2025
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

ID (1)