Use of Vasopressors in Hypotension Associated With Spinal Anaesthesia in Caesarean Sections

January 29, 2026 updated by: Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Comparıson of the effectıveness of ephedrıne and norepınephrıne ın the Treatment of hypotensıon developıng ın spınal anaesthesıa durıng Caesarean sectıon surgerıes

This study was designed as a prospective randomised study. In this study, the researchers planned to evaluate the effect of intravenous vasopressor agents administered to patients undergoing caesarean section under spinal anaesthesia on the incidence of hypotension. Our other aim was to evaluate perioperative haemodynamic data, maternal side effects and neonatal outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Caesarean section is a significant procedure in obstetric patients and constitutes the vast majority of such operations. Regional anaesthesia is currently used in these patients, predominantly spinal anaesthesia. Considering the maternal and foetal side effects of hypotension associated with spinal anaesthesia, it is necessary to prevent this. Vasopressors such as phenylephrine, ephedrine and norepinephrine are used for this purpose. To this end, the researchers aimed to evaluate the effect of ephedrine or norepinephrine administered in patients undergoing caesarean section under spinal anaesthesia on the incidence of hypotension.

Study Type

Interventional

Enrollment (Actual)

70

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 Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Başakşehir Çam and Sakura City Hospital

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 patients aged 18-45
  • Pregnant patients with ASA 2
  • Healthy pregnant women with a gestational age of 37-41 weeks

Exclusion Criteria:

  • Pregnant patients with >ASA III Emergency cases multiple pregnancy preterm pregnancy pregnant women with foetal anomaly and placental anomaly those diagnosed with pre-eclampsia and eclampsia those with maternal cardiovascular and cerebrovascular disease body mass index > 40 kg/m² pregnant women with contraindications for spinal anaesthesia and who do not consent to the study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 mg ephedrine intravenously after spinal anaesthesia
Group 1: Group administered 10 mg ephedrine intravenously after spinal anaesthesia
Procedure: Patients who received 10 mg of ephedrine intravenously after spinal anaesthesia during caesarean section
To prevent intraoperative hypotension, researchers administered 10 mg intravenous ephedrine to a group of patients after spinal anaesthesia.
Experimental: 8 mcg of norepinephrine intravenously following spinal anaesthesia
Group 2: The group administered 8 mcg of norepinephrine intravenously following spinal anaesthesia
Procedure: Patients who received 8 mcg intravenous norepinephrine after spinal anaesthesia during caesarean section
To prevent intraoperative hypotension, researchers administered 8 mcg intravenous norepinephrine to a group of patients after spinal anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative hypotension
Time Frame: Intraoperative
Our primary objective was to compare the incidence of intraoperative hypotension. In the study, hypotension was defined as a blood pressure level lower than 80% of the baseline systolic arterial pressure (SAP). Hypotension was determined in both groups when the systolic arterial pressure was lower than 80% despite the administration of ephedrine or norepinephrine after spinal anaesthesia
Intraoperative
Assessment of intraoperative heart rate
Time Frame: intraoperative
Our secondary objective is to assess the intraoperative heart rate. These time intervals were at the start of surgery, after the patient was placed in the sitting position, after spinal anaesthesia was administered, 3 minutes, 6 minutes, 9 minutes, 12 minutes, and 15 minutes after spinal anaesthesia, 1 minute after delivery, 10 minutes, 20 minutes, 30 minutes, and 40 minutes after delivery, and at the end of surgery.
intraoperative

Collaborators and Investigators

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

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 3, 2021

Primary Completion (Actual)

August 3, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-24695

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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