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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05846555
Other study ID # 137/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2023
Est. completion date December 5, 2023

Study information

Verified date April 2023
Source Gaziosmanpasa Research and Education Hospital
Contact sibel bektas
Phone 02129453030
Email sibel-bektas@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date December 5, 2023
Est. primary completion date September 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
urologic surgery
surgery

Locations

Country Name City State
Turkey Gaziosmanpasa TREH Istanbul Gaziosmanpasa
Turkey Gaziosmanpasa TREH Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary intracranial pressure changes during Spinal and general anesthesia 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
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