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Percutaneous trans-arterial angioplasty(PTA) is one of the peripheral arterial occlusive disease(PAOD) treatment. During and after PTA, ischemia-reperfusion pain is induced so proper analgesia is important. ischemia-reperfusion injury is due to reactive oxygen species. Dexmedetomidine has analgesic, sedative and anti oxidant effect. So the investigators research the patient's satisfaction that are given the dexmedetomidine during PTA procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in the dexmedetomidine group | Experimental | Patients in the dexmedetomidine group are given 1 μg/kg/h of dexmedetomidine for 10 minutes on initiation of the procedure and then 0.2-0.7 μg/kg/h until end of the procedure and are given 1.2-7.2 μg/kg/h of remifentanil until end of the procedure |
|
| Patients in the midazolam group | Active Comparator | Patients in the midazolam group are given midazolam 0.02-0.05mg/kg bolus on initiation of the procedure and are given 1.2-7.2 μg/kg/h of remifentanil until end of the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug |
| ||
| midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| patient's satisfaction | patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied) | 1 hour after the procedure (PTA) |
| patient's satisfaction | patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied) | 6 hours after the procedure (PTA) |
| patient's satisfaction | patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied) | 12 hours after the procedure (PTA) |
| patient's satisfaction | patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied) | 24 hours after the procedure (PTA) |
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Inclusion Criteria:
Exclusion Criteria: Subjects are ineligible if they have the below condition
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| remifentanil | Drug | - remifentanil will be administered to both dexmedetomidine and midazolam group as a routine part of procedure and it is no of interest of the protocol |
|
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |