NCT06869304

Brief 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. 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.

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
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 4, 2025

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • MoCA

    Preoperative MoCA test scores

    preoperatively

  • MoCA

    postoperative MoCA test scores

    day 1

Secondary Outcomes (1)

  • NIRS

    intraoperatively

Interventions

Preoperative and postoperative MoCA test scores

Eligibility Criteria

Age65 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Betül Güven Aytaç, Assoc.prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 11, 2025

Study Start

March 15, 2025

Primary Completion

April 15, 2025

Study Completion

October 30, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations