Cerebral Oxygen Consumption Response to Increased Oxygen Supply and Postoperative Delirium in Older Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Cerebral Oxygen Utilization Assessment.
- Who it may be relevant to
- Registry conditions: Delirium - Postoperative, Cerebral Oxygenation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Incidence of Postoperative Delirium [Time frame: Up to 3 days after surgery]
Secondary outcome measures (1)
- Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR) [Time frame: During surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT07463586 · B-2602-1024-002