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Clinical Trials/NCT07452367
NCT07452367RecruitingNot Applicable

Evaluation of the Relationship Between Bilateral Optic Nerve Sheath Diameter (ONSD) Measurements and Postoperative Cognitive Functions in Bentall Surgeries: A Prospective Observational Study

Bursa Yuksek Ihtisas Training and Research Hospital1 site in 1 country100 target enrollmentStarted: August 30, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Relationship between perioperative bilateral ONSD measurements and postoperative cognitive function

Study Overview

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.

Detailed Description

Bentall procedure is a complex cardiac surgery involving replacement of the ascending aorta, aortic root, and aortic valve using a mechanical or bioprosthetic valve conduit and vascular graft. It is commonly performed for aortic aneurysm, aortic dissection, or connective tissue disorders such as Marfan syndrome. The procedure carries a mortality rate of 2-10% and a neurological complication rate of 3-8%, including stroke and postoperative cognitive dysfunction (POCD).Postoperative neurological complications in Bentall surgery are influenced by both patient-related and surgery-related factors. Patient-related risk factors include advanced age (>70 years), low educational level, pre-existing cognitive impairment, carotid artery stenosis, and acute type A dissection. Surgery-related risk factors include prolonged CPB and deep hypothermic arrest duration, cerebral perfusion technique, prosthesis type, prolonged mechanical ventilation, postoperative infection, low cardiac output, and anticoagulation compliance.

The optic nerve sheath (ONS) is a continuation of the intracranial dura mater surrounding the subarachnoid space. It expands in response to elevated intracranial pressure (ICP), particularly in the anterior retrobulbar region. Ultrasound measurement of ONSD is a well-validated, non-invasive bedside method for detecting elevated ICP and has been studied in various clinical settings.

Bentall surgeries involving CPB may affect intracranial dynamics through multiple mechanisms including oxygenation fluctuations, electrolyte disturbances, hemodilution, blood transfusion requirements, temperature variations, total circulatory arrest, prolonged surgical duration, and embolic events. Therefore, perioperative monitoring of intracranial status is of particular importance in these patients.

Study Procedures:

All patients will have the following baseline data recorded: age, sex, BMI, ASA classification, comorbidities, smoking and alcohol use, medications, ejection fraction (EF), EuroSCORE, and educational level.Preoperative assessments (T0) will include MoCA test, bilateral NIRS-based cerebral oximetry, and bilateral ONSD measurement by ultrasound while breathing room air.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Relationship between perioperative bilateral ONSD measurements and postoperative cognitive function

Time Frame: Preoperative baseline to postoperative hospital discharge at 30 days

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Anıl Onur

Specialist in Anesthesiology and Reanimation

Bursa Yuksek Ihtisas Training and Research Hospital

Study Sites (1)

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