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

January 8, 2019 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: dexmedetomidine
Drug: remifentanil
- 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
Active Comparator: 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
Drug: midazolam
Drug: remifentanil
- 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's satisfaction
Time Frame: 1 hour 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)
1 hour after the procedure (PTA)
patient's satisfaction
Time Frame: 6 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)
6 hours after the procedure (PTA)
patient's satisfaction
Time Frame: 12 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)
12 hours after the procedure (PTA)
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)
24 hours after the procedure (PTA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

April 2, 2018

Study Completion (Actual)

April 2, 2018

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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