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

NCT ID: NCT06869304

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-15

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neurocognitive Disorder Robotic Assisted Laparoscopic Radical Prostatectomy Near Infrared Spectroscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Montreal Cognitive Assessment

Preoperative and postoperative MoCA test scores

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Betül Güven

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital Bilkent

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Betül Güven Aytaç, Assoc.prof.

Role: CONTACT

+905073578351

Other Identifiers

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TABED2-24-570

Identifier Type: -

Identifier Source: org_study_id

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