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NCT Number: NCT03485612

Analysis of Change of Optic Nerve Sheath Diameter in in Patients Operated for Urological Reasons

The assessment of the diameter of the optic nerve sheath (ONSD) using ultrasound can be a very helpful tool in the assessment of increased intracranial pressure in patients operated for urological procedures.

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Key information

Conditions

Anaesthetic Complication Neurological Central Nervous System Depression

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital in Cracow

Krakow, 31-501, Poland

About this study

Advantages of using ultrasound in the assessment of intracranial pressure:

simple, bedside examination, repetitive, generally available, cheap, no exposure to X-rays, no need to transport the patient to the CT laboratory

Differential diagnosis:

Widening of the size of the optic nerve sheath outside of increased intracranial pressure may occur in the following pathologies:

optic neuritis optic nerve injuries meningioma of the optic nerve arachnoid cyst around the optic nerve tumors of the cavernous sinus Blood edema may occur due to impaired blood flow. The research is to determine whether the patient's position for urological procedures is safe for the patients and whether as a result of staying in such a position there is no development of cerebral edema.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing urologic operation
  • Adults 18 to 90 years of age
  • American Society of Anesthesiologists Physical grade 1-3

Exclusion criteria

  • Patients who did not agree to participate in the study
  • Patients with ophthalmic diseases
  • Patients with previous history of ophthalmic surgery
  • Patients with neurological disorders
  • Patients with history of head surgery due to neurological disorders
  • Patients with history of disease with increased intracranial pressure
  • Patients with history of disease with increased intraocular pressure

Treatment and study plan

Change of Optic Nerve Sheath Diameter

Diagnostic Test

In patients, the optic nerve sheath width (ONSD) examination will be performed twice: for the first time immediately after general anesthesia and again after surgery after placing the patient in a position on the back.

Primary outcomes

  1. Optic Nerve Sheath Diameter

    Time frame: 10 hours

Secondary outcomes

  1. neurological complications

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2018
Registry last updated
Feb 24, 2020

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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