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

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 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


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

Value
https://center6.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