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The purpose of this study is to determine whether postoperative analgesia pump continuous infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and Postoperative cognitive dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine+routine PCIA | Active Comparator | PCIA pump was provided after surgery, which consisted of 3 ug/kg sufentanil and 3 ug/kg dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h. |
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| Routine PCIA | Sham Comparator | 3 ug/kg sufentanil without dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4. | 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS for pain | Pain was assessed by NRS (Numeric Rating Scale) : assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". | 3 days after surgery |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D017409 | Sufentanil |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Sufentanyl | Drug | Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed. |
|
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| Saline | Drug | Saline is used to dilute other drugs |
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including hypotension, hypertension, bradycardia, tachycardia, hypoxemia, and in-terventions (adjustment or stop study drug infusion or intravenous administration).
| 3 days after surgery |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D005283 |
| Fentanyl |
| D010880 | Piperidines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |