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NCT02929095 Clinical Trial

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

Peripheral Arterial Occlusive Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02929095
Other study ID # 4-2016-0701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date April 2, 2018

Study information
Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date April 2, 2018
Est. primary completion date April 2, 2018
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 79 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• dexmedetomidine

• midazolam

• 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

Locations
Country Name City State
Korea, Republic of Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 1 hour after the procedure (PTA)
Primary 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) 6 hours after the procedure (PTA)
Primary 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) 12 hours after the procedure (PTA)
Primary 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) 24 hours after the procedure (PTA)
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