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

February 20, 2020 updated by: Tomasz Skladzien, Jagiellonian University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

69

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

  • Poland
      • Kraków, Poland, 31-501
        • University Hospital in Cracow

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
change of the optic nerve sheath diameter
The test group will be male and female patients, aged over 18 and below 90 years of age. Each patient will be operated for urological reasons in the position for lithotomy.
Diagnostic test: Change of Optic Nerve Sheath Diameter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic Nerve Sheath Diameter
Time Frame: 10 hours
10 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
neurological complications
Time Frame: 5 days
5 days

Collaborators and Investigators

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

Sponsor

Jagiellonian 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, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 10, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (Actual)

April 2, 2018

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.30.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are undecided on this point.

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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