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

NCT07317258 | Not Yet Recruiting

• 1 other identifier: Cerebral Perfusion in Position
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Perfusion Pressure; Trendelenburg

Keywords

TRANSCRANİAL DOPPLER USG; CEREBRAL PERFUSİON; TRENDELENBURG; NIRS; EEG; PATİENT STATE İNDEKS; ROBOTİC SURGERY; PROSTATEKTOMİ

Outcome Measures

Primary Outcomes (2)

• Cerebral Oxygenation Measured by Near-Infrared Spectroscopy (NIRS)

  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)

  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 Outcomes (2)

• Mean Arterial Pressure (MAP) at Predefined Perioperative Time Points

  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

  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

Study Arms (1)

Patients Robotic Prostate Surgery

Men aged 18 to 80 undergoing robotic prostate surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hanife Kabukcu: lead

Study Sites (1)

Akdeniz University

Antalya, Antalya, Turkey (Türkiye)

Location

Related Publications (2)

• Kalmar AF, Dewaele F, Foubert L, Hendrickx JF, Heeremans EH, Struys MM, Absalom A. Cerebral haemodynamic physiology during steep Trendelenburg position and CO(2) pneumoperitoneum. Br J Anaesth. 2012 Mar;108(3):478-84. doi: 10.1093/bja/aer448. Epub 2012 Jan 17.

  PMID: 22258202 RESULT

• Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.

  PMID: 20167583 RESULT

Study Officials

• Hanife Kabukcu

  Akdeniz University

  STUDY DIRECTOR

• Sinem Omca

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanife Kabukcu

CONTACT

+905337319555; hanifekabukcu@akdeniz.edu.tr

Sinem Omca

CONTACT

+905061187398; snmomca@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: finalization of the results

Locations

TU (1)