The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- patient's satisfaction
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients in the dexmedetomidine group
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
Intervention: dexmedetomidine (Drug)
Patients in the dexmedetomidine group
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
Intervention: remifentanil (Drug)
Patients in the midazolam group
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
Intervention: midazolam (Drug)
Patients in the midazolam group
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
Intervention: remifentanil (Drug)
Outcomes
Primary Outcomes
patient's satisfaction
Time Frame: 24 hours after the procedure (PTA)
patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied)
Secondary Outcomes
No secondary outcomes reported