Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:22 AM
Study NCT ID:
NCT07317258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cerebral Perfusion in Supine and Steep Trendelenburg Positions During Robotic Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-24', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral Oxygenation Measured by Near-Infrared Spectroscopy (NIRS)', 'timeFrame': '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', 'description': '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.'}, {'measure': 'Middle Cerebral Artery Blood Flow Velocity Measured by Transcranial Doppler Ultrasonography (TCD)', 'timeFrame': '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', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Arterial Pressure (MAP) at Predefined Perioperative Time Points', 'timeFrame': '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', 'description': 'Mean arterial pressure (mmHg) will be recorded continuously and extracted at predefined perioperative time points to assess hemodynamic changes associated with patient positioning.'}, {'measure': 'End-Tidal CO₂ (EtCO₂) at Predefined Perioperative Time Points', 'timeFrame': '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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRANSCRANİAL DOPPLER USG', 'CEREBRAL PERFUSİON', 'TRENDELENBURG', 'NIRS', 'EEG', 'PATİENT STATE İNDEKS', 'ROBOTİC SURGERY', 'PROSTATEKTOMİ'], 'conditions': ['Cerebral Perfusion Pressure', 'Trendelenburg']}, 'referencesModule': {'references': [{'pmid': '22258202', 'type': 'RESULT', 'citation': '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': '20167583', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nAdditionally, 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.\n\nThe aim was to determine the relationship between ICP estimation, cerebral oxygenation, and hemodynamic variables during supine and steep Trendelenburg positions in robotic prostatectomy.', 'detailedDescription': '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.\n\nAn 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.\n\nSeveral 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.\n\nTCD 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).\n\nPI is calculated using the formula:\n\nPI = (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).\n\nRI is calculated as:\n\nRI = (Peak systolic velocity - End diastolic velocity) / Peak systolic velocity.\n\nAn 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.\n\nNormal 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.\n\nIn 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.\n\nNIRS 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.\n\nIn 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.\n\nPreoperative 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients aged 18 to 80 years undergoing robotic prostate surgery under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale patients aged 18 to 80 years\n\nASA physical status I-III\n\nScheduled for robotic prostate surgery under general anesthesia\n\nAble and willing to provide written informed consent\n\nExclusion Criteria:\n\nDecline or inability to provide informed consent\n\nAge \\<18 years or \\>80 years\n\nInability to perform ultrasonographic measurements or to maintain the required surgical position\n\nPresence of intracranial space-occupying lesions\n\nHistory of cerebrovascular accident (CVA) or carotid artery occlusion\n\nKnown neurological disorders (e.g., epilepsy)'}, 'identificationModule': {'nctId': 'NCT07317258', 'briefTitle': 'Evaluation of Cerebral Perfusion in Supine and Steep Trendelenburg Positions During Robotic Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Evaluation of Cerebral Perfusion in Supine and Steep Trendelenburg Positions During Robotic Prostatectomy', 'orgStudyIdInfo': {'id': 'Cerebral Perfusion in Position'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Robotic Prostate Surgery', 'description': 'Men aged 18 to 80 undergoing robotic prostate surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'state': 'Antalya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sinem Omca', 'role': 'CONTACT', 'email': 'snmomca@gmail.com', 'phone': '+905061187398'}, {'name': 'Hanife Kabukcu', 'role': 'CONTACT', 'email': 'hanifekabukcu@akdeniz.edu.tr', 'phone': '+905337319555'}, {'name': 'Sinem Omca', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hanife Kabukcu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'centralContacts': [{'name': 'Hanife Kabukcu', 'role': 'CONTACT', 'email': 'hanifekabukcu@akdeniz.edu.tr', 'phone': '+905337319555'}, {'name': 'Sinem Omca', 'role': 'CONTACT', 'email': 'snmomca@gmail.com', 'phone': '+905061187398'}], 'overallOfficials': [{'name': 'Hanife Kabukcu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akdeniz University'}, {'name': 'Sinem Omca', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'IPD used in publishing the results', 'accessCriteria': 'finalization of the results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanife Kabukcu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Hanife Kabukcu', 'investigatorAffiliation': 'Akdeniz University'}}}}