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

Yonsei University

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Drug: remifentanil; Drug: dexmedetomidine; Drug: midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02929095

4-2016-0701

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Male

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Patients in the dexmedetomidine group

Experimental group

Description:

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

Treatment:

Drug: remifentanil

Drug: dexmedetomidine

Patients in the midazolam group

Active Comparator group

Description:

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

Treatment:

Drug: midazolam

Drug: remifentanil