Peripheral Arterial Occlusive DiseaseNCT02929095
The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction
A study testing dexmedetomidine, midazolam and remifentanil in people with Peripheral Arterial Occlusive Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years, men only
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- dexmedetomidine, midazolam and remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2016to 2 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- heart failure
- fever (>38 degree)
- uncontrolled hypertension
- cognitive dysfunction
- disabling mental change disorder
- being unable to communicate or speak Korean
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- dexmedetomidine, midazolam, remifentanil
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
midazolamDrug
remifentanilDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients in the dexmedetomidine group | Experimental | 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 Receives: Drug: dexmedetomidine; Drug: remifentanil |
| Patients in the midazolam group | Active comparator | 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 Receives: Drug: midazolam; Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour after the procedure (PTA)
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)
Measured: 6 hours after the procedure (PTA)
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)
Measured: 12 hours after the procedure (PTA)
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)
Measured: 24 hours after the procedure (PTA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929095
- Sponsor's protocol ID
- 4-2016-0701
- Status last verified
- Jan 2019
- First submitted
- 5 Oct 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction
- ClinicalTrials.gov ID
- NCT02929095
- Acronym / sponsor ID
- 4-2016-0701
- Conditions
- Peripheral Arterial Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in the dexmedetomidine group | Experimental | Drug: dexmedetomidine, Drug: remifentanilPatients 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 | Active comparator | Drug: midazolam, Drug: remifentanilPatients 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 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidine | Drug | Patients in the dexmedetomidine group |
| midazolam | Drug | Patients in the midazolam group |
| 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 | Drug | Patients in the dexmedetomidine group, Patients in the midazolam group |
Primary outcome
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine, midazolam and remifentanil in people with Peripheral Arterial Occlusive Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient's satisfaction (time frame: 1 hour after the procedure (PTA)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.