UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering
Title of the study (Brief title)	Study for changes of electrocardiogram (ECG) waveform of pediatric patients
Region	Japan

Condition
Condition	intraoral lesion
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study on changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The changes of R-wave height at the end of anesthetic induction, after 1h, 2h and 3h due to ECG filtering.
Key secondary outcomes	The changes of T-wave height and the ratio of height of R-wave and T-wave at the end of anesthetic induction, after 1h, 2h and 3h due to ECG filtering.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	2 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	Pediatric patients under 6 year-old undergoing oral treatment under general anesthesia.
Key exclusion criteria	Patients with heart disease.
Target sample size	20

Research contact person
Name of lead principal investigator	Takeshi Yokoyama
Organization	kyushu university
Division name	dental anesthesiology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-6480
Email	yokoyama@dent.kyushu-u.ac.jp

Public contact
Name of contact person	Jun Hirokawa
Organization	kyushu university
Division name	dental anesthesiology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-6480
Homepage URL
Email	hj8823@gmail.com

Sponsor
Institute	department of dental anesthesiology, kyushu university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2017 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 07 Day
Anticipated trial start date	2017 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry	2018 Year 03 Month 12 Day
Date trial data considered complete	2018 Year 03 Month 12 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study on changes of electrocardiogram (ECG) waveform of pediatric patients under anesthesia due to ECG filtering

Management information
Registered date	2017 Year 12 Month 15 Day
Last modified on	2018 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034717