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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015600
Receipt No. R000018127
Scientific Title Effects of fentanyl on cardiac repolarization during tracheal intubation in children
Date of disclosure of the study information 2014/11/04
Last modified on 2017/12/19

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Basic information
Public title Effects of fentanyl on cardiac repolarization during tracheal intubation in children
Acronym Fentanyl on cardiac repolarization during tracheal intubation in children
Scientific Title Effects of fentanyl on cardiac repolarization during tracheal intubation in children
Scientific Title:Acronym Fentanyl on cardiac repolarization during tracheal intubation in children
Region
Japan

Condition
Condition Children scheduled for non-cardiac surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effects of fentanyl on cardiac repolarization during tracheal intubation in children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cardiac repolarization time during tracheal intubation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 intravenous administration of fentanyl
Interventions/Control_2 intravenous administration of normal saline
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
1 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Children scheduled for non-cardiac surgery under general anesthesia
Key exclusion criteria Children taking medication that afffects QT interval, having any cardiac rhythm other than sinus rhythm, or with a preoperative abnormal QT prolongation
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kotaro Hori
Organization Osaka City General Hospital
Division name Department of Anesthesiology
Zip code
Address Miyakojima-hondori 2-13-22, Miyakojimaku, Osaka 545-0021, Japan
TEL +81-6-6929-1221
Email k.hori@med.osaka-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kotaro Hori
Organization Osaka City General Hospital
Division name Department of Anesthesiology
Zip code
Address Miyakojima-hondori 2-13-22, Miyakojimaku, Osaka 545-0021, Japan
TEL +81-6-6929-1221
Homepage URL
Email k.hori@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City General Hospital
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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 04 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
2014 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 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
2014 Year 11 Month 04 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018127

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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