Evaluation of Cerebral Perfusion in Supine and Steep Trendelenburg Positions During Robotic Prostatectomy

December 24, 2025 updated by: Hanife Kabukcu

Evaluation of Cerebral Perfusion in Supine and Steep Trendelenburg Positions During Robotic Prostatectomy Robotic endoscopic radical prostatectomy requires pneumoperitoneum and the steep Trendelenburg position to ensure optimal surgical visualization. However, this combination may increase intracranial pressure (ICP) and alter cerebral blood flow and oxygenation.

This study aimed to evaluate cerebral perfusion changes in patients undergoing robotic prostatectomy by using Transcranial Doppler (TCD) and Near-Infrared Spectroscopy (NIRS). Cerebral blood flow velocity in the middle cerebral artery and pulsatility index (PI) were measured to estimate ICP, while NIRS was used to assess cerebral oxygen saturation.

Additionally, arterial blood gas parameters (PCO₂, PO₂, Hb), end-tidal CO₂, and mean arterial pressure (MAP) were recorded. Pre- and postoperative Mini-Mental State Examination (MMSE) scores were compared to evaluate potential cognitive effects.

The aim was to determine the relationship between ICP estimation, cerebral oxygenation, and hemodynamic variables during supine and steep Trendelenburg positions in robotic prostatectomy.

Study Overview

Status

Not yet recruiting

Detailed Description

The use of robotic endoscopic radical prostatectomy has the potential to improve surgical outcomes and reduce complications compared to open radical prostatectomy. Robotic endoscopic abdominal surgery involves carbon dioxide (CO₂) insufflation to create pneumoperitoneum and requires the Trendelenburg position to provide adequate surgical visualization.

An increase in intra-abdominal pressure due to pneumoperitoneum leads to various physiological changes. The combination of steep Trendelenburg positioning and pneumoperitoneum during robotic prostatectomy is known to cause intracranial hypertension. The elevation of intra-abdominal pressure and Trendelenburg positioning increases intracranial pressure (ICP) and alters cerebral blood flow (CBF). These changes in cerebral hemodynamics may have detrimental effects on cerebral oxygenation.

Several invasive and non-invasive techniques are available for monitoring ICP and cerebral perfusion pressure (CPP). Among non-invasive methods, Transcranial Doppler ultrasonography (TCD) and Near-Infrared Spectroscopy (NIRS) are reliable and safe monitoring tools.

TCD measures blood flow velocities in the major arteries of the Circle of Willis. Based on TCD-derived data, several formulas have been proposed to estimate ICP, such as the Pulsatility Index (PI) and Resistance Index (RI).

PI is calculated using the formula:

PI = (Peak systolic velocity - End diastolic velocity) / Mean velocity. A normal PI typically ranges between 0.5 and 1.2. Under normal systemic hemodynamic conditions, an elevated PI (particularly >2) suggests reduced cerebral perfusion pressure (CPP).

RI is calculated as:

RI = (Peak systolic velocity - End diastolic velocity) / Peak systolic velocity.

An RI greater than 0.75-0.8 is considered abnormal. RI is conceptually similar to PI (both increase in cases of low CPP), although PI is more widely used in clinical practice.

Normal ICP values vary with age and body position, but are generally 5-15 mmHg in healthy supine adults, 3-7 mmHg in children, and 1.5-6 mmHg in infants.

In cases of elevated ICP or circulatory hypotension, cerebral perfusion pressure (CPP) decreases. CPP is calculated as the difference between mean arterial pressure (MAP) and ICP. MAP is obtained by adding one-third of the pulse pressure (the difference between systolic and diastolic pressure) to the diastolic pressure.

NIRS technology was recently developed to enable continuous and non-invasive monitoring of regional cerebral tissue oxygen saturation for various clinical indications. The differing absorption spectra of oxygenated and deoxygenated hemoglobin at different light wavelengths allow for assessment of the balance between cerebral oxygen supply and demand.

In this study, the correlation between cerebral oxygen saturation measured by NIRS and estimated ICP calculated from TCD-derived middle cerebral artery (MCA) flow velocity and pulsatility index was evaluated. In addition, arterial blood gas parameters (PCO₂, PO₂, hemoglobin), end-tidal CO₂ (EtCO₂), and mean arterial pressure (MAP) were included in the analysis.

Preoperative and postoperative Mini-Mental State Examination (MMSE) tests were administered to assess potential cognitive changes and to compare our non-invasive monitoring results with clinical outcomes.

Study Type

Observational

Enrollment (Estimated)

60

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 Contact Backup

Study Locations

    • Antalya
      • Antalya, Antalya, Turkey (Türkiye)
        • Akdeniz University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sinem Omca
        • Sub-Investigator:
          • Hanife Kabukcu

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male patients aged 18 to 80 years undergoing robotic prostate surgery under general anesthesia.

Description

Inclusion Criteria:

Male patients aged 18 to 80 years

ASA physical status I-III

Scheduled for robotic prostate surgery under general anesthesia

Able and willing to provide written informed consent

Exclusion Criteria:

Decline or inability to provide informed consent

Age <18 years or >80 years

Inability to perform ultrasonographic measurements or to maintain the required surgical position

Presence of intracranial space-occupying lesions

History of cerebrovascular accident (CVA) or carotid artery occlusion

Known neurological disorders (e.g., epilepsy)

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

Cohorts and Interventions

Group / Cohort
Patients Robotic Prostate Surgery
Men aged 18 to 80 undergoing robotic prostate surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Oxygenation Measured by Near-Infrared Spectroscopy (NIRS)
Time Frame: 1.Upon arrival in the operating room (baseline) 2.10 minutes after endotracheal intubation 3.30 minutes after placement in the Trendelenburg position 4.10 minutes before returning to the supine position 5. Postoperative 1 hour
Cerebral oxygenation will be assessed using near-infrared spectroscopy (NIRS). Regional cerebral oxygen saturation (%) will be continuously monitored, and values will be recorded at predefined perioperative time points.
1.Upon arrival in the operating room (baseline) 2.10 minutes after endotracheal intubation 3.30 minutes after placement in the Trendelenburg position 4.10 minutes before returning to the supine position 5. Postoperative 1 hour
Middle Cerebral Artery Blood Flow Velocity Measured by Transcranial Doppler Ultrasonography (TCD)
Time Frame: 1.Supine position, 10 minutes after endotracheal intubation 2.30 minutes after placement in the Trendelenburg position 3.10 minutes before returning to the supine position 4.After returning to the supine position 5.Postoperative 1 hour
Middle cerebral artery (MCA) blood flow velocity will be measured using transcranial Doppler ultrasonography (TCD). MCA mean flow velocity (cm/s) will be recorded at predefined perioperative time points.
1.Supine position, 10 minutes after endotracheal intubation 2.30 minutes after placement in the Trendelenburg position 3.10 minutes before returning to the supine position 4.After returning to the supine position 5.Postoperative 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure (MAP) at Predefined Perioperative Time Points
Time Frame: 1.Upon arrival in the operating room 2.10 minutes after endotracheal intubation 3.30 minutes after placement in the Trendelenburg position 4.10 minutes before returning to supine 5.Postoperative 1 hour
Mean arterial pressure (mmHg) will be recorded continuously and extracted at predefined perioperative time points to assess hemodynamic changes associated with patient positioning.
1.Upon arrival in the operating room 2.10 minutes after endotracheal intubation 3.30 minutes after placement in the Trendelenburg position 4.10 minutes before returning to supine 5.Postoperative 1 hour
End-Tidal CO₂ (EtCO₂) at Predefined Perioperative Time Points
Time Frame: 1.Upon arrival in the operating room 2.10 minutes after endotracheal intubation 3.30 minutes after placement in the Trendelenburg position 4.10 minutes before returning to supine 5.Postoperative 1 hour
End-tidal carbon dioxide (mmHg) will be monitored continuously and documented at several standardized perioperative time points to assess potential effects of Trendelenburg positioning and pneumoperitoneum on ventilation.
1.Upon arrival in the operating room 2.10 minutes after endotracheal intubation 3.30 minutes after placement in the Trendelenburg position 4.10 minutes before returning to supine 5.Postoperative 1 hour

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Hanife Kabukcu, Akdeniz University
  • Principal Investigator: Sinem Omca, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD used in publishing the results

IPD Sharing Time Frame

The data will be available from October 5, 2025, to October 30, 2026, and will be shared after the study results have been finalized and published.

IPD Sharing Access Criteria

finalization of the results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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