UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010022
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute University of Fukui Faculty of Medical Sciences, Division of cardiovascular Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011731

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.