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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004150
Receipt No. R000004982
Scientific Title The effect of remifentanil on cardiac conduction system in pediatric patients undergoing radiofrequency catheter ablation
Date of disclosure of the study information 2010/09/02
Last modified on 2010/09/02

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Basic information
Public title The effect of remifentanil on cardiac conduction system in pediatric patients undergoing radiofrequency catheter ablation
Acronym The effect of remifentanil on cardiac conduction system in pediatric patients undergoing radiofrequency catheter ablation
Scientific Title The effect of remifentanil on cardiac conduction system in pediatric patients undergoing radiofrequency catheter ablation
Scientific Title:Acronym The effect of remifentanil on cardiac conduction system in pediatric patients undergoing radiofrequency catheter ablation
Region
Japan

Condition
Condition Wolff-Parkinson-White syndrome
Classification by specialty
Cardiology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to clarify the mechanisms of remifentanil induced bradycardia by investigating the effects of remifentanil on cardiac conduction system including sinus node function and AH interval.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After anesthetic induction and catheter insertion, CSACT (calculated sinoatrial conduction time) is measured during first EPS (electrophysiological study). And then, remifentanil is administered at a rate of 0.2 or 0.4 microg/kg/min. Almost 10 minutes after remifentanil administration, second EPS and CSACT measurement is performed.
Key secondary outcomes As with mentioned above, CSNRT (corrected sinus node recovery time), RR interval, and AH interval are measured before and during remifentanil administration.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Remifentanil 0.2 microg/kg/min
Interventions/Control_2 Remifentanil 0.4 microg/kg/min
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
3 years-old <=
Age-upper limit
16 years-old >=
Gender Male and Female
Key inclusion criteria After obtaining written informed consents from the parents, ASA physical status 1 - 2 pediatric patients with Wolff-Parkinson-White syndrome who are scheduled to undergo radiofrequency catheter ablation will be prospectively enrolled in this study.
ASA physical status
P1 A normal healthy patient
P2 A patient with mild systemic disease
P3 A patient with severe systemic disease
P4 A patient with severe systemic disease that is a constant threat to life
P5 A moribund patient who is not expected to survive without the operation
P6 A declared brain-dead patient whose organs are being removed for donor purposes
Key exclusion criteria Exclusion criteria
1) obesity
2) allergy to the trial or companion drugs
3) previous history of kidney, and/or liver disease.
4) patients with severe heart diseases including cardiomyopathy, valvulopathy, and congenital cardiac diseases
5) patients deemed unsuitable for the study by investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Iranami
Organization Japanese Red Cross Society Wakayama Medical Center
Division name Department of Anesthesiology
Zip code
Address Komatsubara-dori 4-20, Wakayama 640-8558, Japan
TEL 073-422-4171
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Japanese Red Cross Society Wakayama Medical Center
Division name Department of Anesthesiology
Zip code
Address
TEL 073-422-4171
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology
Japanese Red Cross Society Wakayama Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 日本赤十字社和歌山医療センター(和歌山県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 02 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 Completed
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 02 Day
Last modified on
2010 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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