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| Name | Class |
|---|---|
| Affiliated Wenling Hospital of Wenzhou Medical University | OTHER |
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To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Huperzine A Injection |
|
| Control group | Placebo Comparator | 0.9% Sodium Chloride Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Chloride Injection | Drug | 0.9% Sodium Chloride Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium within 7 days after operation | Delirium will be evaluated by The 3-dimensional Confusion Assessment Method(3D-CAM) and delirium rating scale-revised-98(DRS-R-98) scale form. | 7 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| type of delirium | diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form | evaluated at screening, 24 hours, 48 hours, 72 hours after operation |
| severity of delirium | diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Li, MD. PhD | Contact | 13587876896 | liting1021@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Ting Li, MD. PhD | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| Huperzine A Injection |
| Drug |
Huperzine A Injection |
|
| evaluated at screening, 24 hours, 48 hours, 72 hours after operation |
| duration of delirium | diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form | evaluated at screening, 24 hours, 48 hours, 72 hours after operation |
| length of hospital stay | total number of days of hospital stay | from the day of operation to the day of discharge, around 7 to 14 days |
| Economic indicators (total hospitalization cost, anesthesia cost, operation cost). | costs at hospital | through study completion, up to 2 months |
| Occurrence of complications | pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc. | through study completion, up to 2 months |
| Incidence of Mortality | rate of Mortality during the hospital stay and follow-up within 30 days after discharge | the day of hospital discharge, and the day of follow-up, around 30 days after discharge |
| the total score of Mini-mental State Examination scale | Mini-mental State Examination scale | evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge |
| the score of EuroQol (EQ-5D) scale | EQ-5D scale | 96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge |
| 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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C050426 | huperzine A |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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