UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004150 |
|---|---|
| Receipt number | 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 13:06:29 |
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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
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
Sponsor or person
Institute
Department of Anesthesiology
Japanese Red Cross Society Wakayama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004982
