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NCT Number: NCT07317258

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanife Kabukcu

CONTACT

[email protected]

+905337319555

Sinem Omca

CONTACT

[email protected]

+905061187398

Sponsors and collaborators

Lead sponsor

Hanife Kabukcu

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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