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

NCT07463586 | Recruiting

• 1 other identifier: B-2602-1024-002
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium - Postoperative; Cerebral Oxygenation

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  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.

  Up to 3 days after surgery

Secondary Outcomes (1)

• Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR)

  During surgery

Other Outcomes (1)

• Predictive Performance of ΔHbO-HbR for Postoperative Delirium

  Up to 3 days after surgery

Study Arms (1)

Older patients undergoing elective laparoscopic surgery

Adults 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.

Other: Intraoperative Cerebral Oxygen Utilization Assessment

Interventions

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.

Older patients undergoing elective laparoscopic surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from patients scheduled for elective laparoscopic surgery at Seoul National University Bundang Hospital, a tertiary academic medical center in the Republic of Korea. Eligible patients will be identified during routine preoperative evaluation and approached for study participation prior to surgery.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Soowon Lee, MD, PhD

CONTACT

+82-31-787-7499; soowonlee@snubh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 11, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)