NCT02929095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

October 5, 2016

Last Update Submit

January 8, 2019

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

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

Drug: dexmedetomidineDrug: 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

Drug: midazolamDrug: remifentanil

Interventions

dexmedetomidineDRUG
Patients in the dexmedetomidine group
midazolamDRUG
Patients in the midazolam group
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

Patients in the dexmedetomidine groupPatients in the midazolam group

Eligibility Criteria

Age20 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

DexmedetomidineMidazolamRemifentanil

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 10, 2016

Study Start

October 1, 2016

Primary Completion

April 2, 2018

Study Completion

April 2, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

KR(1)