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

Primary Purpose

Peripheral Arterial Occlusive Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine
midazolam
remifentanil
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Arterial Occlusive Disease

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients in the dexmedetomidine group

Patients in the midazolam group

Arm 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

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
October 5, 2016
Last Updated
January 8, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02929095
Brief Title
The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients in the dexmedetomidine group
Arm Type
Experimental
Arm 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
Arm Title
Patients in the midazolam group
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Type
Drug
Intervention Name(s)
remifentanil
Intervention Description
- 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
Primary Outcome Measure Information:
Title
patient's satisfaction
Description
patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied)
Time Frame
1 hour after the procedure (PTA)
Title
patient's satisfaction
Description
patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied)
Time Frame
6 hours after the procedure (PTA)
Title
patient's satisfaction
Description
patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied)
Time Frame
12 hours after the procedure (PTA)
Title
patient's satisfaction
Description
patient's satisfaction is measured by 5-point numerical rating scale ((0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied)
Time Frame
24 hours after the procedure (PTA)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

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

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