Actively Recruiting
Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
Led by Seoul National University Bundang Hospital · Updated on 2026-04-02
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study focuses on adults aged 65 years and older who are undergoing elective laparoscopic surgery under general anesthesia. Researchers aim to understand if the brain's ability to use oxygen during surgery is linked to the risk of developing postoperative delirium. The study evaluates whether reduced cerebral oxygen consumption responsiveness during surgery increases the chance of delirium after the operation. During surgery, participants will have their brain oxygen levels monitored using a non-invasive forehead sensor based on functional near-infrared spectroscopy technology. Oxygen levels in the anesthesia may be temporarily adjusted within routine clinical ranges to assess the brain's response. No experimental oxygen or extra treatments will be given beyond standard care. After surgery, participants will be observed for up to three days to check for signs of delirium. Participants will undergo brain oxygen measurements during surgery and be assessed for delirium through clinical evaluations in the days following surgery. Researchers will track the occurrence of postoperative delirium as the primary outcome and measure cerebral oxygen utilization response during surgery as a secondary outcome. The total participation involves the surgery day and a three-day postoperative monitoring period to gather necessary data for the study.
CONDITIONS
Brief Title
Cerebral Oxygen Consumption Response to Increased Oxygen Supply and Postoperative Delirium in Older Surgical Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective laparoscopic surgery under general anesthesia
- Age 65 years or older
You will not qualify if you...
- 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 such as Parkinson's disease, stroke, or prior brain surgery
- Severe hepatic dysfunction with AST or ALT greater than 120 IU/L
- Severe renal dysfunction with estimated GFR less than 15 mL/min/1.73 m²
- Persistent severe hemodynamic instability with mean arterial pressure less than 60 mmHg
- Skin conditions preventing placement of the forehead fNIRS sensor
- Combined surgical procedures performed concurrently
- Planned postoperative admission to the intensive care unit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo elective laparoscopic surgery under general anesthesia during which cerebral oxygen levels are monitored non-invasively using a forehead sensor to assess the brain's oxygen utilization response within routine anesthesia care.
1 intraoperative monitoring session
Duration - Up to 3 days after surgery
Participants are observed for up to 3 days after surgery to evaluate the occurrence of postoperative delirium.
Daily visits or assessments for up to 3 days
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
Research Team
S
Soowon Lee, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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