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The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Droperidol 1.25mg/0.5ml |
|
| Placebo group | Placebo Comparator | Normal saline 0.5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droperidol Injection | Drug | About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium within 7 days after operation | Incidence of delirium within 7 days after operation | 7 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of delirium | Severity of Postoperative delirium | From the end of operation to 7 days after opertation |
| Delirium-free days | Delirium-free days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, MD,PHD | Contact | +8618616514088 | diansansu@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Diansan Su, MD,PHD | Renji Hospital, Shanghai Jiaotong University, School of Medcine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
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| Saline | Drug | About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection. |
|
|
| From the end of operation to 7 days after opertation |
| Postoperative hospital duration | Postoperative hospital duration | From end of operation to discharge, an average of 1 week |
| cognitive function at 30 days and 6 months | cognitive function at 30 days and 6 months | 30 days and 6 months after surgery |
| Henan Provincial People Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Pudong | Shanghai Municipality | 200127 | China |
|
| Second hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | China |
|
| Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH) | Not yet recruiting | Chengdu | Sichuan | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
|
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D014570 | Urologic Diseases |
| D005831 | Genital Diseases, Female |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000091662 | Genital Diseases |
| 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 |
|---|---|
| D004329 | Droperidol |
| C007792 | Fumigant 93 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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