UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of fentanyl on cardiac repolarization during tracheal intubation in children
Title of the study (Brief title)	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
Name of lead principal investigator	Kotaro Hori
Organization	Osaka City General Hospital
Division name	Department of Anesthesiology
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
Name of contact person	Kotaro Hori
Organization	Osaka City General Hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018127