Effect of Tourniquet Application on Optic Nerve Sheath Diameter

February 12, 2021 updated by: Bahar Say, Zonguldak Bulent Ecevit University

The Effect of Tourniquet Application on Optic Nerve Sheath Diameter and Cerebral Oxygenation During Lower Extremity Surgery

The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1

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
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

lower extremity surgery with tourniquet

Description

Inclusion Criteria:

  • ASA I-II risk group over the age of 18
  • Operation planned under general anesthesia
  • Lower extremity surgery with a tourniquet
  • Agreeing to volunteer for research with an informed consent form

Exclusion Criteria:

  • Emergency surgical procedures
  • neurological disease, carotid disease
  • Previous intracranial or ocular surgery
  • Neurological symptoms
  • cerebral edema, high IntraCranial Pressure
  • Presence of glaucoma
  • Body mass index (BMI)> 35
  • Uncontrolled hypertension
  • Diabetic retinopathy
  • anemia
  • coronary artery disease
  • peripheral artery disease

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optic nerve diameter
Time Frame: during the surgery
measuring the change in optic nerve diameter
during the surgery
regional cerebral oxgenation
Time Frame: during the surgery
measurement rSo2 by Near Infrared spectroscopy
during the surgery

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit 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)

April 15, 2019

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-58-03/04

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

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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