The Effect of Steep Trendelenburg Position on Neurocognitive Functions in Robotic Radical Prostatectomy Cases

March 10, 2025 updated by: Betül Güven, Ankara City Hospital Bilkent

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital Bilkent
        • Contact:
          • Özlem Balkız Soyal, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients aged 65 years and older with ASA II-III risk scores, undergoing robotic radical prostatectomy

Description

Inclusion Criteria:

  • Age ≥ 65 years
  • ASA II-III risk score
  • Patients scheduled for robotic radical prostatectomy
  • Patients who voluntarily agree to participate

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA
Time Frame: preoperatively
Preoperative MoCA test scores
preoperatively
MoCA
Time Frame: day 1
postoperative MoCA test scores
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIRS
Time Frame: intraoperatively
NIRS values (right & left)
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED2-24-570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurocognitive Disorder

Clinical Trials on Montreal Cognitive Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe