Assessment of Brain Oxygen Drops During Surgery and Related Risk Factors for Cognitive Problems After Heart Surgery

NCT07361068 | Completed

• 1 other identifier: 011-KAEK-25 2023/02-15
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines whether decreases in brain oxygen levels during cardiac surgery are linked to postoperative cognitive dysfunction and identifies other factors that may increase the risk of cognitive impairment.

Conditions

Cognitive Dysfunction, Postoperative; Cognitive Dysfunction; Cardiac Surgery

Keywords

Cognitive dysfunction; Near infrared spectroscopy; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Cognitive Dysfunction (POCD)

  Postoperative cognitive dysfunction (POCD) is defined as a decline in cognitive performance assessed using the Mini-Mental State Examination (MMSE), with a score of ≤23 at any postoperative assessment compared with a preoperative baseline MMSE score of ≥24. This primary outcome evaluates the association between intraoperative cerebral oxygen desaturation, measured by near-infrared spectroscopy (NIRS) as a reduction of \>20% from baseline regional cerebral oxygen saturation (rSO₂), and postoperative cognitive dysfunction following cardiac surgery with cardiopulmonary bypass.

  Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.

Secondary Outcomes (9)

• Intraoperative Cerebral Oxygen Desaturation Measured by NIRS

  Perioperatively (during surgery) through immediate postoperative period (upon ICU admission).

• Postoperative Cognitive Performance Over Time Assessed by MMSE

  Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.

• Operation Time

  From skin incision to skin closure during surgery

• Cardiopulmonary Bypass (CPB) Duration

  From initiation to termination of cardiopulmonary bypass during surgery (single intraoperative assessment).

• Aortic Cross-Clamp (ACC) Duration

  From application to removal of the aortic cross-clamp during surgery (single intraoperative assessment)

Study Arms (2)

Group POCD: Patients develop cognitive dysfunction after cardiac surgery

The POCD group (n=24) comprised patients undergoing elective cardiac surgery with cardiopulmonary bypass who developed postoperative cognitive dysfunction, defined as an MMSE score ≤23 at any postoperative assessment. ( Postoperative day 4 ,7, 30)

Group non-POCD : Patients did not develop postoperative cognitive dysfunction

The non-POCD group (n = 50) consisted of adult patients undergoing elective cardiac surgery with cardiopulmonary bypass whose MMSE scores remained ≥24 at all postoperative assessments, indicating no postoperative cognitive dysfunction.

Eligibility Criteria

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

Study Population

Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia

You may qualify if:

• Planned elective CPB surgery
• Provision of written informed consent
• Absence of communication barriers that could interfere with preoperative and postoperative MMSE assessment
• No history of cerebrovascular disease
• Preoperative MMSE score ≥24
• Education level of at least high school
• Absence of any frontal deformity that could hinder NIRS monitoring

You may not qualify if:

• Preoperative use of antipsychotic or antidepressant medications
• Emergency cardiac surgery indication
• Presence of ≥50% carotid artery stenosis

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Traning and Research Hospital

Bursa, 16000, Turkey (Türkiye)

Location

Related Publications (2)

• Hu YN, Hsieh TH, Tsai MT, Chien CY, Roan JN, Huang YC, Liang SF. Cognitive Function Deterioration After Cardiopulmonary Bypass: Can Intraoperative Optimal Cerebral Regional Tissue Oxygen Saturation Predict Postoperative Cognitive Function? J Cardiothorac Vasc Anesth. 2023 May;37(5):715-723. doi: 10.1053/j.jvca.2023.01.025. Epub 2023 Feb 2.

  PMID: 36813631 RESULT

• Lewis C, Parulkar SD, Bebawy J, Sherwani S, Hogue CW. Cerebral Neuromonitoring During Cardiac Surgery: A Critical Appraisal With an Emphasis on Near-Infrared Spectroscopy. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2313-2322. doi: 10.1053/j.jvca.2018.03.032. Epub 2018 Mar 20.

  PMID: 30100271 RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation doctor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 22, 2026
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 25, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (1)