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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929095
Enrollment
70
Registered
2016-10-10
Start date
2016-10-01
Completion date
2018-04-02
Last updated
2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Occlusive Disease

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.

Interventions

DRUGdexmedetomidine
DRUGmidazolam
DRUGremifentanil

\- 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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patient's satisfaction1 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026