RecruitingNCT07463586

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

Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy


Sponsor

Seoul National University Bundang Hospital

Enrollment

80 participants

Start Date

Mar 11, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria2

  • Patients undergoing elective laparoscopic surgery under general anesthesia
  • Age 65 years or older

Exclusion Criteria12

  • 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

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Interventions

OTHERIntraoperative 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.


Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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