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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation in Urological Surgery While Lithotomy Position
- ClinicalTrials.gov ID
- NCT05846555
- Acronym / sponsor ID
- 137/22
- Conditions
- Urological Manifestations, Anesthesia
- Keywords
- optic nerve sheath diameter, lithotomy position, near infrared spectrometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 6 Sep 2023 (estimated)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | – | Procedure: urologic surgerypatients observed under general anesthesia |
| spinal anesthesia | – | Procedure: urologic surgerypatients observed under spinal anesthesia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urologic Surgery Patients
Key inclusion criteria (2 listed)
- ASA 1-2-3, patients
- over 18 years of age who will undergo urological surgery
Key exclusion criteria (3 listed)
- Existing disease that causes an increase in intracranial pressure
- Patients with optic nerve pathology,
- Ophthalmologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urologic surgerysurgery | Procedure or surgery | general anesthesia, spinal anesthesia |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zuhal çavuş, MD principal investigator
gaziosmanpasa TREH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urological Manifestations and Anesthesia, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sibel bektas (02129453030, sibel-bektas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.