Urological ManifestationsNCT05846555
Optic Nerve Sheath Diameter in Urologic Surgery
An observational study of Urological Manifestations and Anesthesia, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urological Manifestations, Anesthesia
- What is being tested?
- urologic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Apr 2023to 5 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urologic Surgery Patients
Who may be able to join
- ASA 1-2-3, patients
- over 18 years of age who will undergo urological surgery
Who cannot join
- Existing disease that causes an increase in intracranial pressure
- Patients with optic nerve pathology,
- Ophthalmologic diseases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
sibel bektaş, prof.MD, sibel-bektas@yahoo.com
- Not yet recruiting
Gaziosmanpaşa TREH
Istanbul
zuhal çavuş, MD, +902129453000 ext. 1436, zuhalcavus74@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Urological Manifestations, Anesthesia
- Being tested
- urologic surgery
- Keywords
- optic nerve sheath diameter, lithotomy position, near infrared spectrometer
- Medical subject headings
- Urological Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urologic surgeryProcedure or surgery
surgery
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | patients observed under general anesthesia Receives: Procedure: urologic surgery | |
| spinal anesthesia | patients observed under spinal anesthesia Receives: Procedure: urologic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure changes during Spinal and general anesthesia
optic nerve sheat diameter as a predictor of intracranial pressure
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start18 Apr 2023
- Primary completion6 Sep 2023 (estimated)
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
- Investigators
- zuhal çavuş, MD, Principal investigator, gaziosmanpasa TREH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846555
- Sponsor's protocol ID
- 137/22
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided