Optic Nerve Sheath Diameter in Urologic Surgery

May 3, 2023 updated by: Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital

Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation in Urological Surgery While Lithotomy Position

The investigators aimed to determine intracranial pressure changes during spinal and general anesthesia by using optic nerve sheath diameter and near infrared spectrometer in urologic surgery patients in lithotomy position. Also the investigators plan to evaluate to measure intrathoracic pressure effects to intracranial pressure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be divided into 2 groups as those who underwent general anesthesia and spinal anesthesia.Both groups at the specified times.

(The patient is supine for both groups before the start of the anesthesia procedure.) position T0, for group G, T1G 2 minutes after intubation, T1S 2 minutes after spinal anesthesia for group S, two T2, lithotomy 5 minutes after the lithotomy position for the group lithotomy to T3 30 minutes after the T4, T5 in PACU ) 60 minutes after optic nerve sheath diameter (OSC) values and lung assessment (LUS), cerebral cerebral palsy with Near-infrared spectroscopy (NIRS) oxygenation, mean arterial pressure, peripheral oxygen saturation, serum sodium, arterial carbon dioxide values and heart rate values will be recorded and significant statistical differences will be evaluated.

Study Type

Observational

Enrollment (Anticipated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Not yet recruiting
        • Gaziosmanpaşa TREH
        • Contact:
    • Gaziosmanpaşa
      • Istanbul, Gaziosmanpaşa, Turkey, 34255

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Urologic Surgery Patients

Description

Inclusion Criteria:

  • ASA 1-2-3, patients
  • over 18 years of age who will undergo urological surgery

Exclusion Criteria:

  • Existing disease that causes an increase in intracranial pressure
  • Patients with optic nerve pathology,
  • Ophthalmologic diseases

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
general anesthesia
patients observed under general anesthesia
Procedure: urologic surgery
surgery
spinal anesthesia
patients observed under spinal anesthesia
Procedure: urologic surgery
surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intracranial pressure changes during Spinal and general anesthesia
Time Frame: position T0, for group G, T1G 2 minutes after intubation, T1S 2 minutes after spinal anesthesia for group S, two T2, lithotomy 5 minutes after the lithotomy position for the group lithotomy to T3 30 minutes after the T4, T5 in PACU ) 60 minutes after
optic nerve sheat diameter as a predictor of intracranial pressure
position T0, for group G, T1G 2 minutes after intubation, T1S 2 minutes after spinal anesthesia for group S, two T2, lithotomy 5 minutes after the lithotomy position for the group lithotomy to T3 30 minutes after the T4, T5 in PACU ) 60 minutes after

Collaborators and Investigators

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

Sponsor

Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: zuhal çavuş, MD, Gaziosmanpaşa TREH

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 18, 2023

Primary Completion (Anticipated)

September 6, 2023

Study Completion (Anticipated)

December 5, 2023

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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