How older adults' brains use extra oxygen during surgery and whether that links to postoperative delirium
Official title: Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
Run by Seoul National University Bundang Hospital · NCT07463586 · Data updated 2026-11-12
This project tries to see if reduced brain oxygen use during elective laparoscopic surgery under general anesthesia increases the chance of postoperative delirium in people aged 65 and older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | March 2028 |
| Study ends | May 2028 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT07463586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 65 years or older who are having elective laparoscopic surgery under general anesthesia and who do not have preexisting dementia or delirium and meet the study's medical exclusion criteria.
✕Probably not a fit
Patients with preexisting dementia or delirium, significant neurologic disease, severe pulmonary or renal failure, planned postoperative ICU admission, or other exclusion conditions are unlikely to benefit from participation in this observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, single-center study enrolling patients aged 65 or older having elective laparoscopic surgery under general anesthesia. During surgery, cerebral oxygenation and oxygen consumption responsiveness to increased oxygen supply will be monitored noninvasively using a forehead sensor (fNIRS/near-infrared oximetry). No changes to routine care are made; investigators will record intraoperative oxygenation patterns and any clinical data relevant to cerebral perfusion. Participants will be screened for postoperative delirium for up to three days after surgery using standard clinical assessments. The study will analyze whether impaired intraoperative cerebral oxygen consumption response is associated with higher rates of postoperative delirium.
Why it matters
Potential benefit: If successful, this could help identify older patients at higher risk of postoperative delirium so clinicians can target monitoring or oxygen-management strategies to prevent it.
How similar studies have gone: Prior observational work has linked low intraoperative cerebral oxygenation to postoperative delirium, but measuring the brain's specific oxygen consumption response to increased oxygen supply during surgery is a relatively novel focus.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea Recruiting
Study contacts
- Study coordinator: Soowon Lee, MD, PhD
- Email: soowonlee@snubh.org
- Phone: +82-31-787-7499
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.