Postoperative Cognitive DysfunctionONCOBNCT07452367
Optic Nerve Sheath Diameter and Cognitive Outcomes in Bentall Surgery
An observational study of Postoperative Cognitive Dysfunction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 30 Aug 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Refusal to participate or inability to provide informed consent
- Patients with known psychiatric disorders
- Reoperation (redo surgery)
- Patients with severe renal or hepatic failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa High Specialization Training and Research Hospital
Bursa, Yıldırım, 16300
Anıl O Onur, MD, 05337244608, dr.anilonur@gmail.com
Anıl O Onur, MD
About this study
Official title: Evaluation of the Relationship Between Bilateral Optic Nerve Sheath Diameter (ONSD) Measurements and Postoperative Cognitive Functions in Bentall Surgeries: A Prospective Observational Study
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.
Read the 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.
Following preoxygenation and routine anesthesia induction, a central venous catheter will be placed. Bilateral NIRS and bilateral ONSD measurements will be performed at the following time points:
T0: Preoperative (room air) T1: 5 minutes after anesthesia induction T2: CPB initiation T3: Maximum hypothermic period T4: Aortic cross-clamp removal T5: CPB termination T6: After sternal closure, before ICU transfer
At each time point, mean arterial pressure (MAP), arterial blood gas values including hematocrit, PaO2, PaCO2, lactate, and pH will also be recorded.
Intraoperative data to be recorded include: anesthetic agent doses, total opioid and inhalation agent consumption, analgesic technique (fascial plane block or IV analgesia), surgical duration, CPB duration, cross-clamp duration, methylprednisolone dose if used, mannitol amount if used, cerebral perfusion type, TCA duration and temperature if applicable, surgical technique, prosthesis type, degree of hypothermia, vasopressor type and dose, blood transfusion volume, total urine output, and fluid balance.
Postoperative Follow-up:
Patients will be transferred to the cardiovascular surgery ICU and managed by the ICU team according to their standard protocols. The study team will not interfere with clinical management.
Postoperative assessments will include:
Bilateral ONSD measurement within the first postoperative hour and after extubation if applicable CAM-ICU delirium assessment twice daily during ICU stay and once daily on the ward RASS sedation score during ICU stay MoCA test after extubation and before hospital discharge VAS pain scores at postoperative 0, 6, 12, and 24 hours
Additional outcome data to be collected: extubation time, ICU length of stay, hospital length of stay, postoperative complications, need for mechanical circulatory support, reintubation, reoperation, blood transfusion volume, analgesic consumption, and mortality if applicable.
The observation period begins before anesthesia induction and ends at hospital discharge or mortality.
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Bentall surgery, Optic nerve sheath diameter, Postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline to postoperative hospital discharge at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start30 Aug 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anıl Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Anıl O Onur, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452367
- Sponsor's protocol ID
- 2025/07-01
- Acronym
- ONCOB
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared due to patient confidentiality and privacy concerns in accordance with local ethical and legal regulations
Publications
Onur A, Okmen K, Onur T, Karaca U, Ataseven M, Cecer S, Demirel A, Aytunur CS, Ata F, Balkaya AN, Aydin OS, Erdolu B, Pala AA. Association between perioperative optic nerve sheath diameter and postoperative delirium after Bentall surgery: a prospective observational study. Front Med (Lausanne). 2026 Sep 15;13:1940776. doi: 10.3389/fmed.2026.1940776. eCollection 2026.
PubMed 42812559
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Bilateral Optic Nerve Sheath Diameter (ONSD) Measurements and Postoperative Cognitive Functions in Bentall Surgeries: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07452367
- Acronym / sponsor ID
- ONCOB / 2025/07-01
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Bentall surgery, Optic nerve sheath diameter, Postoperative cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Following preoxygenation and routine anesthesia induction, a central venous catheter will be placed. Bilateral NIRS and bilateral ONSD measurements will be performed at the following time points:
T0: Preoperative (room air) T1: 5 minutes after anesthesia induction T2: CPB initiation T3: Maximum hypothermic period T4: Aortic cross-clamp removal T5: CPB termination T6: After sternal closure, before ICU transfer
At each time point, mean arterial pressure (MAP), arterial blood gas values including hematocrit, PaO2, PaCO2, lactate, and pH will also be recorded.
Intraoperative data to be recorded include: anesthetic agent doses, total opioid and inhalation agent consumption, analgesic technique (fascial plane block or IV analgesia), surgical duration, CPB duration, cross-clamp duration, methylprednisolone dose if used, mannitol amount if used, cerebral perfusion type, TCA duration and temperature if applicable, surgical technique, prosthesis type, degree of hypothermia, vasopressor type and dose, blood transfusion volume, total urine output, and fluid balance.
Postoperative Follow-up:
Patients will be transferred to the cardiovascular surgery ICU and managed by the ICU team according to their standard protocols. The study team will not interfere with clinical management.
Postoperative assessments will include:
Bilateral ONSD measurement within the first postoperative hour and after extubation if applicable CAM-ICU delirium assessment twice daily during ICU stay and once daily on the ward RASS sedation score during ICU stay MoCA test after extubation and before hospital discharge VAS pain scores at postoperative 0, 6, 12, and 24 hours
Additional outcome data to be collected: extubation time, ICU length of stay, hospital length of stay, postoperative complications, need for mechanical circulatory support, reintubation, reoperation, blood transfusion volume, analgesic consumption, and mortality if applicable.
The observation period begins before anesthesia induction and ends at hospital discharge or mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 42812559Onur A, Okmen K, Onur T, Karaca U, Ataseven M, Cecer S, Demirel A, Aytunur CS, Ata F, Balkaya AN, Aydin OS, Erdolu B, Pala AA. Association between perioperative optic nerve sheath diameter and postoperative delirium after Bentall surgery: a prospective observational study. Front Med (Lausanne). 2026 Sep 15;13:1940776. doi: 10.3389/fmed.2026.1940776. eCollection 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared due to patient confidentiality and privacy concerns in accordance with local ethical and legal regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anıl O Onur, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anıl O Onur, MD (+905337244608, dr.anilonur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between perioperative bilateral ONSD measurements and postoperative cognitive function (time frame: Preoperative baseline to postoperative hospital discharge at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.