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

Sponsor

Jagiellonian University (Other)

Overall Status

Completed

CT.gov ID

NCT03485612

Collaborator

(none)

Enrollment

Location

20.5

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anaesthetic Complication Neurological Central Nervous System Depression	Diagnostic Test: Change of Optic Nerve Sheath Diameter

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 Design

Study Type:

Observational

Actual Enrollment :

69 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 15, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Optic Nerve Sheath Diameter [10 hours]

Secondary Outcome Measures

neurological complications [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital in Cracow	Kraków		Poland	31-501

Sponsors and Collaborators

Jagiellonian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomasz Skladzien, senior assistant, Jagiellonian University

ClinicalTrials.gov Identifier:

NCT03485612

Other Study ID Numbers:

1072.6120.30.2018

First Posted:

Apr 2, 2018

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Tomasz Skladzien, senior assistant, Jagiellonian University

Optic Nerve Sheath Diameter

Urological Anaesthesia

point of care USG

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Feb 24, 2020