The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

August 24, 2025 updated by: Zakaria Ahmed Zakaria, Assiut University
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.

Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.

Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.

The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women scheduled for cesarean section under spinal anesthesia
  • Gestational age of at least 37 weeks

Exclusion Criteria:

  • Patient refusal
  • Contraindications of spinal anesthesia
  • Allergy to the study drug
  • Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
  • patients with cardiac morbidities
  • Hypertensive disorders of pregnancy.
  • Prepartum hemorrhage

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Norepinephrine (0.1)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.
Drug: Norepinephrine (0.1)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.
Active Comparator: Norepinephrine (0.075)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.
Drug: Norepinephrine (0.075)
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency of post-spinal hypotension
Time Frame: During the first hour after the subarachnoid block
During the first hour after the subarachnoid block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood pressure (Systolic, diastolic, and mean)
Time Frame: During the first hour after the subarachnoid block
During the first hour after the subarachnoid block
Heart rate
Time Frame: During the first hour after the subarachnoid block
During the first hour after the subarachnoid block
Doses of atropine and ephedrine
Time Frame: Intraoperative
Intraoperative
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Time Frame: 1, 5, and 10 minutes after delivery
Ranges from 0 (the worst score) to 10 (the best score)
1, 5, and 10 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 24, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Noradrenaline in CS under SA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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