Optic Nerve Sheath Diameter and Cognitive Outcomes in Bentall Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years

Scheduled for elective Bentall procedure

Requiring cardiopulmonary bypass (CPB)

Willing to participate and able to provide informed consent

Disqualifiers

Age below 18 or above 80 years

Emergency Bentall surgery

Pre-existing diagnosed cognitive impairment or dementia

History of prior stroke or neurological disease

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
Preoperative baseline to postoperative hospital discharge at 30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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