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

Not Applicable

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Drug: dexmedetomidine; Drug: midazolam; Drug: remifentanil

• Registration Number: NCT02929095
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Primary Completion: 2018-04-02
• Study Completion: 2018-04-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients in the dexmedetomidine group	dexmedetomidine	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	midazolam	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
Patients in the dexmedetomidine group	remifentanil	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	remifentanil	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

Primary Outcome Measures

Name	Time	Method
patient's satisfaction	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)

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of