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This prospective, randomized controlled trial aims to investigate the perioperative use of lemborexant, an orexin receptor antagonist, for reducing postoperative delirium (POD) in elderly patients undergoing general anesthesia.
Patients in the intervention group will receive lemborexant, while those in the control group will receive a matching placebo. The primary outcome is the incidence of POD within 5 days after surgery. Secondary outcomes include sleep quality on postoperative days 1, 3, and 5, delirium severity and subtype, hospital anxiety and depression scores, quality of emergence from anesthesia, adverse events, and hematological parameters. The expected findings will provide evidence on the safety and efficacy of prophylactic perioperative lemborexant in improving postoperative outcomes in older patients, and will offer a theoretical and practical foundation for future research and clinical application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intervention group | Experimental |
| |
| The control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant Pill | Drug | The intervention group will take Lemborexant tablets four times during the perioperative period |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of POD | The incidence of POD within 5 days after surgery | The 1st to 5th day after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative sleep quality | The sleep scale and sleep monitoring equipment will be used for data collection after the operation | On the 1st, 3rd and 5th days after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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| Placebo tablet | Drug | The control group will take placebo tablets with the same appearance, smell and properties as the intervention group four times during the perioperative period |
|
| 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 |