Optic Nerve Sheath Diameter and Cognitive Outcomes in Bentall Surgery

NCT07452367 | Recruiting

• 1 other identifier: 2025/07-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

Bentall surgery; Optic nerve sheath diameter; Postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• Relationship between perioperative bilateral ONSD measurements and postoperative cognitive function

  The Montreal Cognitive Assessment (MoCA) test will be administered preoperatively and after extubation and before hospital discharge to evaluate postoperative cognitive dysfunction (POCD). MoCA assesses multiple cognitive domains including memory, attention, executive function, and abstraction. The relationship between perioperative bilateral optic nerve sheath diameter (ONSD) measurements obtained by ultrasound and the change in MoCA scores will be analyzed to determine whether ONSD can serve as a predictive marker for postoperative cognitive dysfunction in patients undergoing Bentall surgery.This study will evaluate the relationship between changes in optical diameter and postoperative cognitive function. Whether any correlation exists will be assessed based on the study results.

  Preoperative baseline to postoperative hospital discharge at 30 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-80 years scheduled for elective Bentall procedure at Bursa Yuksek Ihtisas Training and Research Hospital. The study population consists of patients with aortic pathologies including aortic aneurysm, aortic dissection, or connective tissue disorders such as Marfan syndrome, requiring ascending aorta and aortic root replacement with cardiopulmonary bypass (CPB) under general anesthesia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa High Specialization Training and Research Hospital

Bursa, Yıldırım, 16300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anıl O Onur, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anıl O Onur, MD

CONTACT

+905337244608; dr.anilonur@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

TU (1)