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

NCT03485612 | Completed DMC

• 1 other identifier: 1072.6120.30.2018
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthetic Complication Neurological; Central Nervous System Depression

Keywords

Optic Nerve Sheath Diameter; Urological Anaesthesia; point of care USG

Outcome Measures

Primary Outcomes (1)

• Optic Nerve Sheath Diameter

  10 hours

Secondary Outcomes (1)

• neurological complications

  5 days

Study Arms (1)

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

Interventions

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.

change of the optic nerve sheath diameter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

University Hospital in Cracow

Krakow, 31-501, Poland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior assistant

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: April 2, 2018
• Study Start: April 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)