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

NCT07463586 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Bundang Hospital

Phase

Observational

Started

2026-03-11

Last updated

2026-04-02

Condition(s) studied

Delirium - PostoperativeCerebral Oxygenation

Investigational drug(s) / intervention(s)

Intraoperative Cerebral Oxygen Utilization Assessment

Intraoperative Cerebral Oxygen Utilization Assessment: Cerebral oxygenation will be monitored intraoperatively using a non-invasive forehead sensor based on functional near-infrared spectroscopy technology. During general anesthesia, the fraction of inspired oxygen (FiO₂) may be temporarily adjusted within the standard clinical range used in routine anesthesia care to evaluate the brain's oxygen utilization response. No experimental oxygen levels or additional therapeutic interventions will be administered beyond standard clinical practice.

Study 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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of Postoperative Delirium — Up to 3 days after surgery
Postoperative delirium diagnosed using 3D-CAM conducted in the post-anesthesia care unit and hospital ward. Delirium will be defined as at least one positive assessment during the first three postoperative days.

Trial sites (1)

Facility	City	Region	Status
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07463586 on ClinicalTrials.gov ↗ ← All trials in South Korea