NCT07452367 Optic Nerve Sheath Diameter and Cognitive Outcomes in Bentall Surgery
| NCT ID | NCT07452367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bursa Yuksek Ihtisas Training and Research Hospital |
| Condition | Postoperative Cognitive Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-30 |
| Primary Completion | 2026-08-30 |
Trial Parameters
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Brief Summary
Bentall surgery is a major cardiac procedure involving replacement of the ascending aorta, aortic root, and aortic valve, typically requiring cardiopulmonary bypass (CPB) and sometimes deep hypothermic circulatory arrest (DHCA). Due to its complexity, it carries a significant risk of postoperative neurological complications including stroke and postoperative cognitive dysfunction (POCD). This prospective observational study aims to evaluate the relationship between perioperative bilateral optic nerve sheath diameter (ONSD) measurements obtained by ultrasound and postoperative cognitive functions in patients undergoing elective Bentall surgery. ONSD is a non-invasive surrogate marker of intracranial pressure that can be measured at the bedside using ultrasound. In addition to routine hemodynamic monitoring and cerebral oximetry (NIRS), bilateral ONSD will be measured at predefined intraoperative and postoperative time points. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) test preoperatively and postoperatively, and delirium will be evaluated using the CAM-ICU scale during ICU stay. The association between perioperative ONSD values and postoperative cognitive outcomes, extubation time, ICU stay, and neurological complications will be analyzed.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 80 years * Scheduled for elective Bentall procedure * Requiring cardiopulmonary bypass (CPB) * Willing to participate and able to provide informed consent * Able to complete the MoCA cognitive assessment test Exclusion Criteria: * Age below 18 or above 80 years * Emergency Bentall surgery * Pre-existing diagnosed cognitive impairment or dementia * History of prior stroke or neurological disease * Significant carotid artery stenosis * Inability to complete the MoCA test (language barrier, illiteracy, visual or hearing impairment) * Refusal to participate or inability to provide informed consent * Patients with known psychiatric disorders * Reoperation (redo surgery) * Patients with severe renal or hepatic failure