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

NCT07463586 — Recruiting, 80 participants, Seoul National University Bundang Hospital

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

RegistryNCT07463586
StatusRecruiting
Study typeObservational
Enrollment80 (Estimated)
SponsorSeoul National University Bundang Hospital (Other)
ConditionsDelirium - Postoperative, Cerebral Oxygenation
InterventionsIntraoperative Cerebral Oxygen Utilization Assessment (Other)
Datesstart 2026-03-11, primary completion 2028-03-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-03-11, last updated 2026-04-02
Locations1 site in South Korea

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Older patients undergoing elective laparoscopic surgeryOther: Intraoperative Cerebral Oxygen Utilization AssessmentAdults aged 65 years and older undergoing elective laparoscopic surgery under general anesthesia will be prospectively observed. During surgery, cerebral oxygen levels will be measured using a non-invasive forehead sensor to assess the brain's oxygen utilization response within the range of routine anesthesia care. Participants will be followed for up to three days after surgery to evaluate the occurrence of postoperative delirium.
  • Intraoperative Cerebral Oxygen Utilization Assessment (Other): 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.

+Outcome measures

Primary outcomes

  • 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.

Secondary outcomes

  • Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR) [During surgery]: Change 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.

Other outcomes

  • Predictive Performance of ΔHbO-HbR for Postoperative Delirium [Up to 3 days after surgery]: Predictive accuracy of intraoperative Δ(HbO-HbR) for postoperative delirium assessed using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) will be calculated to quantify discrimination.

+Eligibility

Sex: All, ages: 65 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Seoul National University Bundang HospitalSeongnam-si, Gyeonggi-doSouth KoreaRecruiting

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