Neurocognitive DisorderNCT06869304
The Effect of Steep Trendelenburg Position on Neurocognitive Functions in Robotic Radical Prostatectomy Cases
An observational study of Neurocognitive Disorder and Robotic Assisted Laparoscopic Radical Prostatectomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of the steep Trendelenburg position in robotic prostatectomy cases, where anesthesia depth is monitored using BIS and cerebral perfusion is tracked with NIRS, and to determine the incidence of neurocognitive dysfunction using the MoCA test in the postoperative period. Read more about this study
- Who is it for?
- Ages 65 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorder, Robotic Assisted Laparoscopic Radical Prostatectomy, Near Infrared Spectroscopy
- What is being tested?
- Montreal Cognitive Assessment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- Men only
- Healthy volunteers accepted
- Older adult
Study population: Patients aged 65 years and older with ASA II-III risk scores, undergoing robotic radical prostatectomy
Who may be able to join
- Age ≥ 65 years
- ASA II-III risk score
- Patients scheduled for robotic radical prostatectomy
- Patients who voluntarily agree to participate
Who cannot join
- Age < 65 years
- History of neurological or psychiatric disorders
- Inability to undergo robotic surgery
- Conversion to open prostatectomy during surgery
- Patients who do not consent to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara City Hospital Bilkent
Ankara
Özlem Balkız Soyal, md
About this study
Official title: Examining the Effect of Steep Trendelenburg Position on Neurocognitive Functions With MoCA Test in Robotic-assisted Radical Prostatectomy Surgeries.
The aim of this study is to evaluate the effects of the steep Trendelenburg position in robotic prostatectomy cases, where anesthesia depth is monitored using BIS and cerebral perfusion is tracked with NIRS, and to determine the incidence of neurocognitive dysfunction using the MoCA test in the postoperative period.
Steep Trendelenburg position and CO₂ pneumoperitoneum during robotic radical prostatectomy lead to significant changes in intracranial pressure and cerebral oxygenation, which may contribute to postoperative neurocognitive dysfunction (POCD). Monitoring anesthesia depth with Bispectral Index (BIS) and cerebral perfusion with Near-Infrared Spectroscopy (NIRS) may help detect early neurocognitive changes, and MoCA test assessments will reveal a measurable decline in cognitive function postoperatively.
- Conditions
- Neurocognitive Disorder, Robotic Assisted Laparoscopic Radical Prostatectomy, Near Infrared Spectroscopy
- Being tested
- Montreal Cognitive Assessment
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Cognitive AssessmentDiagnostic test
Preoperative and postoperative MoCA test scores
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA
Preoperative MoCA test scores
Measured: preoperatively
MoCA
postoperative MoCA test scores
Measured: day 1
Secondary outcomes (1)
NIRS
NIRS values (right \& left)
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisorderStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869304
- Sponsor's protocol ID
- TABED2-24-570
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 11 Mar 2025
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Steep Trendelenburg Position on Neurocognitive Functions With MoCA Test in Robotic-assisted Radical Prostatectomy Surgeries.
- ClinicalTrials.gov ID
- NCT06869304
- Acronym / sponsor ID
- TABED2-24-570
- Conditions
- Neurocognitive Disorder, Robotic Assisted Laparoscopic Radical Prostatectomy, Near Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Mar 2025 (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 aim of this study is to evaluate the effects of the steep Trendelenburg position in robotic prostatectomy cases, where anesthesia depth is monitored using BIS and cerebral perfusion is tracked with NIRS, and to determine the incidence of neurocognitive dysfunction using the MoCA test in the postoperative period.
Steep Trendelenburg position and CO₂ pneumoperitoneum during robotic radical prostatectomy lead to significant changes in intracranial pressure and cerebral oxygenation, which may contribute to postoperative neurocognitive dysfunction (POCD). Monitoring anesthesia depth with Bispectral Index (BIS) and cerebral perfusion with Near-Infrared Spectroscopy (NIRS) may help detect early neurocognitive changes, and MoCA test assessments will reveal a measurable decline in cognitive function postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older with ASA II-III risk scores, undergoing robotic radical prostatectomy
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- ASA II-III risk score
- Patients scheduled for robotic radical prostatectomy
- Patients who voluntarily agree to participate
Key exclusion criteria (5 listed)
- Age < 65 years
- History of neurological or psychiatric disorders
- Inability to undergo robotic surgery
- Conversion to open prostatectomy during surgery
- Patients who do not consent to participate
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 |
|---|---|---|
| Montreal Cognitive AssessmentPreoperative and postoperative MoCA test scores | Diagnostic test | – |
Primary outcome
MoCA
Time frame: preoperatively
Preoperative MoCA test scores
MoCA
Time frame: day 1
postoperative MoCA test scores
1 secondary outcome
NIRS
Time frame: intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorder and Robotic Assisted Laparoscopic Radical Prostatectomy, run by Ankara City Hospital Bilkent at 1 site 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Güven Aytaç, Assoc.prof. (+905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (time frame: preoperatively). The study lists 2 primary outcomes in all. 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 11 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.