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Not yet recruiting NCT07317258

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

Observational Cerebral Perfusion Pressure Trendelenburg

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebral Perfusion Pressure, Trendelenburg. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Akdeniz University — Antalya

Publications

  • 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
  • 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

Identifiers

NCT: NCT07317258 · Cerebral Perfusion in Position

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗