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


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 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


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

Value
https://center6.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