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NCT04758091 Clinical Trial

Effect of Tourniquet Application on Optic Nerve Sheath Diameter

Intracranial Pressure Increase Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04758091
Other study ID # 2019-58-03/04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2019
Est. completion date June 1, 2020

Study information
Verified date February 2021
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date June 1, 2020
Est. primary completion date December 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Zonguldak Bülent Ecevit University Medicine Faculty Zonguldak Kozlu

Sponsors (1)
Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary optic nerve diameter measuring the change in optic nerve diameter during the surgery
Primary regional cerebral oxgenation measurement rSo2 by Near Infrared spectroscopy during the surgery
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