Optic Nerve Sheath Diameter in Urologic Surgery

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05846555

Collaborator

(none)

Enrollment

Locations

7.6

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urological Manifestations Anesthesia	Procedure: urologic surgery

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

46 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 18, 2023

Anticipated Primary Completion Date :

Sep 6, 2023

Anticipated Study Completion Date :

Dec 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
general anesthesia patients observed under general anesthesia	Procedure: urologic surgery surgery
spinal anesthesia patients observed under spinal anesthesia	Procedure: urologic surgery surgery

Arm

Intervention/Treatment

general anesthesia

patients observed under general anesthesia

Procedure: urologic surgery

surgery

spinal anesthesia

patients observed under spinal anesthesia

Procedure: urologic surgery

surgery

Outcome Measures

Primary Outcome Measures

intracranial pressure changes during Spinal and general anesthesia [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpaşa TREH	Istanbul	Gaziosmanpaşa	Turkey	34255
2	Gaziosmanpaşa TREH	Istanbul		Turkey

Sponsors and Collaborators

Gaziosmanpasa Research and Education Hospital

Investigators

Principal Investigator: zuhal çavuş, MD, gaziosmanpasa TREH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Döndü Genc Moralar, Clinical Professor, Gaziosmanpasa Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT05846555

Other Study ID Numbers:

137/22

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by Döndü Genc Moralar, Clinical Professor, Gaziosmanpasa Research and Education Hospital

optic nerve sheath diameter

lithotomy position

near infrared spectrometer

Additional relevant MeSH terms:

Urological Manifestations

Study Results

No Results Posted as of May 6, 2023