The Influence of Leg Elevation on Noradrenaline Requirements During Cesarean Delivery

May 8, 2025 updated by: Mina Adolf Helmy, Cairo University

The Influence of Thirty-degree Leg Elevation on Noradrenaline Requirements Administered as a Prophylactic Variable Infusion During Cesarean Delivery: An Open Label Randomized Controlled Trial

Spinal anesthesia is a widely chosen technique in obstetric theaters due to several advantages, however sympathetic block results in hypotension that carry several consequences on maternal and fetal health, thus early prediction and management takes high priority. in this regards recent recommendations suggest the use of prophylactic vasopressors like noradrenaline, researchers of this study aimed to explore the impact of leg elevation on prophylactic noradrenaline dose

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

after spinal anesthesia, patients will be randomly allocated into 2 groups : Leg elevation group and control group.

noradrenaline will be used as variable infusion starting from 0.05 microgram/kg/min up to 0.14 microgram /kg/minute.

noradrenaline infusion will be continued till delivery of the baby

Study Type

Interventional

Enrollment (Actual)

80

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

  • Egypt
    • Giza Governorate
      • Cairo, Giza Governorate, Egypt, 6890
        • Cairo University

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:

  • full term
  • singleton pregnancy
  • ASA II

Exclusion Criteria:

  • decline to participate
  • baseline SBP <100 mmHg
  • failed spinal anesthesia
  • allergy to local anesthetic
  • coagulopathy

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leg elevation group
leg will be elevated 30 degrees immediately after spinal anesthesia
Device: Leg elevation
leg will be raised 30 degrees after spinal anesthesia using standardized pillow
No Intervention: Control group
Legs will remain supine after spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average noradrenaline requirements
Time Frame: baseline to delivery of the baby
average noradrenaline requirements in both groups (mcg/kg/min)
baseline to delivery of the baby

Secondary Outcome Measures

Outcome Measure
Time Frame
Total noradrenaline requirements
Time Frame: baseline to delivery
baseline to delivery
incidence of spinal hypotension
Time Frame: baseline to delivery
baseline to delivery
incidence of severe hypotension
Time Frame: baseline to delivery
baseline to delivery

Collaborators and Investigators

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

Sponsor

Cairo University

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)

March 14, 2025

Primary Completion (Actual)

May 8, 2025

Study Completion (Actual)

May 8, 2025

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • leg elevation and noradrenalin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be available from corresponding author upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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