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Completed

NCT Number: NCT04758091

Effect of Tourniquet Application on Optic Nerve Sheath Diameter

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.

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Key information

Conditions

Intracranial Pressure Increase Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. optic nerve diameter

    Time frame: during the surgery

    measuring the change in optic nerve diameter

  2. regional cerebral oxgenation

    Time frame: during the surgery

    measurement rSo2 by Near Infrared spectroscopy

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 17, 2021
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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