NCT05846555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

April 13, 2023

Last Update Submit

May 3, 2023

Conditions

Urological ManifestationsAnesthesia

Keywords

optic nerve sheath diameterlithotomy positionnear infrared spectrometer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

general anesthesia

patients observed under general anesthesia

Procedure: urologic surgery

spinal anesthesia

patients observed under spinal anesthesia

Procedure: urologic surgery

Interventions

urologic surgeryPROCEDURE

surgery

general anesthesiaspinal anesthesia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Urologic Surgery Patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaziosmanpaşa TREH

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

RECRUITING

Gaziosmanpaşa TREH

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Urological Manifestations

Interventions

Urologic Surgical Procedures

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • zuhal çavuş, MD

    gaziosmanpasa TREH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sibel bektas

CONTACT

02129453030sibel-bektas@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 6, 2023

Study Start

April 18, 2023

Primary Completion

September 6, 2023

Study Completion

December 5, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Locations

TU(2)