How older adults' brains use extra oxygen during surgery and whether that links to postoperative delirium
Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT07463586 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seongnam-si, Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.