Postspinal Headache and Near Infrared Spectroscopy (NIRS)

December 4, 2019 updated by: Hakan Tapar

Evaluation of the Relationship Between Postspinal Headache and Near Infrared Spectroscopy in Cesarean Section Patients

Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients with cesarean section under spinal anesthesia were included in the study. Before the study, patients were moniterized with NIRS device in the preoperative waiting room.NIRS moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period.

Patients were divided into two groups as those with postspinal headache (Group A) and those with postspinal headache (Group B). In this study, NIRS values between two groups were compared.

Study Type

Observational

Enrollment (Anticipated)

200

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
      • Tokat, Turkey, 60200
        • Recruiting
        • Gaziosmanpasa 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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with cesarean section under spinal anesthesia

Description

Inclusion Criteria:

  • Elective cesarean section

Exclusion Criteria:

  • Not willing to participate in the study
  • Use of anti-psychotic or anti-depressant drugs
  • Patients with headaches

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
Near Infrared spectroscopy
Time Frame: Up to 20 weeks
Tissue oxygenation
Up to 20 weeks

Collaborators and Investigators

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

Sponsor

Hakan Tapar

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 15, 2019

Primary Completion (ANTICIPATED)

December 30, 2019

Study Completion (ANTICIPATED)

March 10, 2020

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (ACTUAL)

December 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-KAEK-167

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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