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

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ClinicalTrials.gov Identifier: NCT03485612
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Tomasz Skladzien, Jagiellonian University

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
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 Type : Observational
Estimated Enrollment : 100 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 : April 15, 2018
Estimated Primary Completion Date : April 2, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Optic Nerve Sheath Diameter [ Time Frame: 10 hours ]

Secondary Outcome Measures :
  1. neurological complications [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485612


Contacts
Contact: Tomasz Skladzien, PhD 506602250 ext +48 t.skladzien@interia.pl

Locations
Poland
University Hospital in Cracow Recruiting
Kraków, Poland, 31-501
Contact: Tomasz Skladzien, PhD    506602250 ext +48    t.skladzien@interia.pl   
Sponsors and Collaborators
Jagiellonian University

Responsible Party: Tomasz Skladzien, senior assistant, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03485612     History of Changes
Other Study ID Numbers: 1072.6120.30.2018
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are undecided on this point.

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

Keywords provided by Tomasz Skladzien, Jagiellonian University:
Optic Nerve Sheath Diameter
Urological Anaesthesia
point of care USG

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders