UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients
Title of the study (Brief title)	The effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients
Region	Japan

Condition
Condition	The pediatric patients undergoing strabismus surgery or tonsillectomy
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The emergence agitation in PACU(PAED scale>10)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved 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	pateients are received Yokukansan suppository 0.2g/kg at induction of anesthesia
Interventions/Control_2	pateients are received only suppository base at induction of anesthesia
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	18 months-old <=
Age-upper limit	120 months-old >
Gender	Male and Female
Key inclusion criteria	American Society of Anesthesiologists physical status 1 or 2 and scheduled to undergo strabismus surgery or tonsillectomy under general anesthesia.
Key exclusion criteria	Patients who have the medial history such as mental retardation, mental disease, taking psycotropics.
Target sample size	100

Research contact person
Name of lead principal investigator	Ka Koui
Organization	Kanagawa children's medical centre
Division name	Department of Anesthesiology
Address	2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
TEL	045-711-2351
Email	kka@kcmc.jp

Public contact
Name of contact person	Ka Koui
Organization	Kanagawa children's medical centre
Division name	Department of Anesthesiology
Address	2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
TEL	045-711-2351
Homepage URL
Email	kka@kcmc.jp

Sponsor
Institute	Kanagawa children's medical centre
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 03 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 23 Day
Anticipated trial start date	2017 Year 03 Month 28 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	2017 Year 03 Month 24 Day
Last modified on	2017 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030591