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Norepinephrine and Phenylephrine for Cesarean Section Hypotension in Spinal Anesthesia

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Study Aim

The study aims to treat and observe changes in blood pH and base excess in women experiencing low blood pressure during cesarean sections with spinal anesthesia using norepinephrine and phenylephrine.

What is being tested

Norepinephrine

+ Phenylephrine

Drug
Who is being recruted

From 18 to 45 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorGeneral Hospital of Ningxia Medical University
Study ContactYi Chen, M.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on addressing a common complication during cesarean sections when spinal anesthesia is used, known as hypotension. Hypotension can occur in a significant number of women undergoing this procedure, leading to discomfort and potential risks for both the mother and newborn. The study aims to compare two approaches to managing this condition: using norepinephrine and phenylephrine either as a preventive measure or as a treatment when hypotension occurs. The main goal is to determine which method better supports the health of newborns, focusing on outcomes like the pH level of the umbilical artery, which is an important indicator of the baby's blood health at birth. Participants in this trial, taking place across multiple centers, will receive either preventive or rescue doses of the vasopressors through a single-blind approach, meaning the participants will not know which treatment they receive. The study uses a crossover and cluster randomized design, allowing researchers to observe the effects of both strategies in the same group of participants over time. This method provides a comprehensive view of how each treatment impacts the health of the mother and newborn during and after cesarean delivery. By evaluating these approaches, researchers hope to improve the management of spinal anesthesia-induced hypotension and enhance neonatal outcomes.

Official TitleProphylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluster Trial
NCT06508359
Principal SponsorGeneral Hospital of Ningxia Medical University
Study ContactYi Chen, M.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
18-45 years
Primipara or multipara
Singleton pregnancy ≥37 weeks
American Society of Anesthesiologists physical status classification II
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5 exclusion criteria prevent from participating
Body height < 150 cm
Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
Hemoglobin < 7g/dl
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A maintenance dose of norepinephrine (0.05 ug/kg/min) infusion simultaneous with spinal anesthesia. The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Group II

Active Comparator
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Spinal anesthesia-induced hypotension is managed by administering a 6 μg intravenous bolus of norepinephrine.

Group III

Experimental
A maintenance dose of phenylephrine (0.625 ug/kg/min) infusion simultaneous with spinal anesthesia. The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Group IV

Active Comparator
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Spinal anesthesia-induced hypotension is managed by administering a 75 μg intravenous bolus of phenylephrine.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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