Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods

February 21, 2025 updated by: İlke Dolgun, Istinye University

Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods: Comparative Analysis of Perfusion Index, Pulse Variability Index, Tissue Oxygen Saturation and Tissue Hemoglobin Index

To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

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

  • Turkey
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey, 34250
        • Istinye 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

Sampling Method

Probability Sample

Study Population

Fifty pregnant women over the age of 18 who underwent elective cesarean section, were American Society of Anesthesia I and II, and agreed to participate in the study.

Description

Inclusion Criteria:

  • Those who underwent elective cesarean section over the age of 18,
  • American Society of Anesthesia I and II,
  • Agree to participate in the study,

Exclusion Criteria:

  • <18 or >45 years,
  • preeclampsia,
  • cardiovascular disorders,
  • fetal abnormalities,
  • not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
  • not agreeing to participate in 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue oxygen saturation
Time Frame: 4 month
which indicates an increase in local tissue perfusion
4 month
tissue hemoglobin index
Time Frame: 4 month
indicating vasodilation
4 month

Collaborators and Investigators

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

Sponsor

Istinye 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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • haseki nırs masimo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Postspinal Hypotension

Clinical Trials on perfusion index

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe