Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
| Registry | NCT07463586 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 80 (Estimated) |
| Sponsor | Seoul National University Bundang Hospital (Other) |
| Conditions | Delirium - Postoperative, Cerebral Oxygenation |
| Interventions | Intraoperative Cerebral Oxygen Utilization Assessment (Other) |
| Dates | start 2026-03-11, primary completion 2028-03-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-03-11, last updated 2026-04-02 |
| Locations | 1 site in South Korea |
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The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia.
The main question it aims to answer is:
\- Does reduced cerebral oxygen consumption responsiveness during surgery increase the risk of postoperative delirium in older patients?
Participants who are undergoing elective laparoscopic surgery under general anesthesia as part of their routine medical care will have brain oxygen levels measured during surgery using a non-invasive forehead sensor, and will be assessed for delirium for up to three days after surgery.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Older patients undergoing elective laparoscopic surgery | Other: Intraoperative Cerebral Oxygen Utilization Assessment | Adults aged 65 years and older undergoing elective laparoscopic surgery under general anesthesia will be prospectively observed. During surgery, cerebral oxygen levels will be measured using a non-invasive forehead sensor to assess the brain's oxygen utilization response within the range of routine anesthesia care. Participants will be followed for up to three days after surgery to evaluate the occurrence of postoperative delirium. |
Sex: All, ages: 65 Years to any
Inclusion Criteria: * Patients undergoing elective laparoscopic surgery under general anesthesia * Age 65 years or older Exclusion Criteria: * Diagnosis of dementia or presence of delirium before surgery * Loss of capacity to provide informed consent * Moderate or severe cerebrovascular stenosis diagnosed before surgery * Moderate or severe obstructive or restrictive pulmonary dysfunction identified on preoperative pulmonary function testing * Requirement for supplemental oxygen therapy before surgery * History of neurological disorders (e.g., Parkinson's disease, stroke) or prior brain surgery * Severe hepatic dysfunction (AST or ALT > 120 IU/L) * Severe renal dysfunction (estimated GFR < 15 mL/min/1.73 m²) * Persistent severe hemodynamic instability (mean arterial pressure < 60 mmHg) * Skin conditions preventing placement of the forehead fNIRS sensor * Combined surgical procedures performed concurrently * Planned postoperative admission to the intensive care unit
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | South Korea | Recruiting |