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

NCT ID: NCT02929095

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-04-02

Brief Summary

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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

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Conditions

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Peripheral Arterial Occlusive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

remifentanil

Intervention Type DRUG

\- 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

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

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

remifentanil

Intervention Type DRUG

\- 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

Interventions

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dexmedetomidine

Intervention Type DRUG

midazolam

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients who are scheduled to undergo percutaneous trans-arterial angioplasty
* American Society of Anesthesiologists (ASA) class I, II, III

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2016-0701

Identifier Type: -

Identifier Source: org_study_id

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