Evaluation of Cerebral Perfusion in Supine and Steep Trendelenburg Positions During Robotic Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorHanife Kabukcu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Male patients aged 18 to 80 years undergoing robotic prostate surgery under general anesthesia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Patients Robotic Prostate Surgery
Trial outcomes
Primary outcomes
1
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.
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 hour2
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.
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 hourSecondary outcomes
1
Mean Arterial Pressure (MAP) at Predefined Perioperative Time Points
Mean arterial pressure (mmHg) will be recorded continuously and extracted at predefined perioperative time points to assess hemodynamic changes associated with patient positioning.
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 hour2
End-Tidal CO₂ (EtCO₂) at Predefined Perioperative Time Points
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.
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 hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanife Kabukcu
Lead sponsor
Akdeniz University
Sponsor institution
Source ClinicalTrials.gov
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