The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction

Study Overview
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Brief Summary
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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.

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: midazolam
* Drug: remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are scheduled to undergo percutaneous trans-arterial angioplasty American Society of Anesthesiologists (ASA) class I, II, III Exclusion Criteria: Subjects are ineligible if they have the below condition psychiatric medication myocardial infarction within 1 year cardiac surgery within 1 year heart failure fever (>38 degree) uncontrolled hypertension cognitive dysfunction disabling mental change disorder being unable to communicate or speak Korean

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients in the dexmedetomidine group<br>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 | Drug: dexmedetomidine<br> <br> Drug: remifentanil<br>* - 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<br>|
| Active Comparator: Patients in the midazolam group<br>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 | Drug: midazolam<br> <br> Drug: remifentanil<br>* - 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |