Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03485612
Other study ID # 1072.6120.30.2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2018
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Poland University Hospital in Cracow Kraków

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Optic Nerve Sheath Diameter 10 hours
Secondary neurological complications 5 days
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT03964350 - Behavior Brain Responses Early Phase 1