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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07463586
Enrollment
80
Registered
2026-03-11
Start date
2026-03-11
Completion date
2028-05-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Oxygenation, Delirium - Postoperative

Brief 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.

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.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative DeliriumUp to 3 days after surgeryPostoperative 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.

Secondary

MeasureTime frameDescription
Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR)During surgeryChange in the difference between oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR), calculated as Δ(HbO-HbR), measured intraoperatively using functional near-infrared spectroscopy during variations in inspired oxygen concentration within the clinically applied range.

Countries

South Korea

Contacts

CONTACTSoowon Lee, MD, PhD
soowonlee@snubh.org+82-31-787-7499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026