RecruitingNot Applicable

Cerebral Oxygen Consumption Response to Increased Oxygen Supply and Postoperative Delirium in Older Surgical Patients

South Korea80 participantsStarted 2026-03-11

Plain-language summary

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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Postoperative Delirium

Timeframe: Up to 3 days after surgery

Trial details

NCT IDNCT07463586

SponsorSeoul National University Bundang Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-03

Contact for this trial

Soowon Lee, MD, PhD

+82-31-787-7499 soowonlee@snubh.org

View on ClinicalTrials.gov More Delirium - Postoperative trials