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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 (FiOâ‚‚) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR) | 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. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive Performance of ΔHbO-HbR for Postoperative Delirium | 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. | Up to 3 days after surgery |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soowon Lee, MD, PhD | Contact | +82-31-787-7499 | soowonlee@snubh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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|
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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