UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010022 |
|---|---|
| Receipt number | R000011731 |
| Scientific Title | Evaluation of the sedative effects of the 3H-dexmedetomdin in the treatment of catheter ablation |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2013/02/12 20:53:47 |
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Basic information
Public title
Evaluation of the sedative effects of the 3H-dexmedetomdin in the treatment of catheter ablation
Acronym
Evaluation of the sedative effects of thedexmedetomdin in the treatment of catheter ablation
Scientific Title
Evaluation of the sedative effects of the 3H-dexmedetomdin in the treatment of catheter ablation
Scientific Title:Acronym
Evaluation of the sedative effects of thedexmedetomdin in the treatment of catheter ablation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the sedative effects of the dexmedetomdin in the treatment of catheter ablation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to achieve adequate sedation level was documented
Key secondary outcomes
Heart rate, mean arterial pressure, respiratory rate, oxygen saturation, the degree of pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dexmedetomdin using group
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Catheter ablation therapy for atrial firillation
2)Age >=20 years, <80 years (Male and Female)
3)A consent form for participating in this study is submitted
Key exclusion criteria
1)Patients with serious disoder in the central nervous system
2)Patients with muscle relaxant drug is required at catheter ablation
3)Having allergy to dexmedetomdin
4)Having allergy to alpha2 antagonist or alpha2 agonist
5)Patients who are pregnant, breastfeeding or intention to becoming pregnant
6)Patients with CHF(>NYHA III)
7)Other patients determined to be inappropriate by physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tada |
Organization
University of Fukui, Faculty of Medical Sciences
Division name
Division of cardiovascular Medicine
Zip code
Address
23-3 Shimoaizuki, Eiheiji-cho, Fukui 910-1193, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Amaya |
Organization
University of Fukui, Faculty of Medical Sciences
Division name
Division of cardiovascular Medicine
Zip code
Address
23-3 Shimoaizuki, Eiheiji-cho, Fukui 910-1193, Japan.
TEL
0776-61-3111
Homepage URL
Sponsor or person
Institute
University of Fukui Faculty of Medical Sciences, Division of cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Fukui Faculty of Medical Sciences, Division of cardiovascular Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2012 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2013 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011731
