NCT07463586 Cerebral Oxygen Consumption Response to Increased Oxygen Supply and Postoperative Delirium in Older Surgical Patients
| NCT ID | NCT07463586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Delirium - Postoperative |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-03-11 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07463586 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Delirium - Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07463586 currently recruiting?
Yes, NCT07463586 is actively recruiting participants. Contact the research team at soowonlee@snubh.org for enrollment information.
Where is the NCT07463586 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT07463586 clinical trial?
NCT07463586 is sponsored by Seoul National University Bundang Hospital. The trial plans to enroll 80 participants.