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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024379
Receipt No. R000027978
Scientific Title The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
Date of disclosure of the study information 2016/10/24
Last modified on 2019/05/15

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Basic information
Public title The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
Acronym The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
Scientific Title The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
Scientific Title:Acronym The effect of ramelteon to prevent emergence agitation after general anesthesia in pediatric patients : a randomized placebo- controlled trial
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of ramelteon 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 45-60min before anesthesia, pateients take ramelteon0.1mg/kg melted with syrup.
Interventions/Control_2 45-60min before anesthesia, pateients take lactose melted with syrup.
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 tonsillectomy under general anesthesia are included in this study.
Key exclusion criteria Patients are excluded from the study if they have the medial history such as mental retardation, mental disease, taking psycotropics or anticonvulsants, cardiac disease and cerebral surgery. Patients who enter hospital on the a.m. of the day of surgery are also excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Maya
Middle name
Last name Komazaki
Organization Kanagawa childrens medical centre
Division name Department of Anesthesiology
Zip code 232-8555
Address 2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
TEL 045-711-2351
Email maya.koma05peony.root.dike@gmail.com

Public contact
Name of contact person
1st name Maya
Middle name
Last name Komazaki
Organization Kanagawa Children's Medical Centre
Division name Department of Anesthesiology
Zip code 232-8555
Address 2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
TEL 045-711-2351
Homepage URL
Email maya.koma05peony.root.dike@gmail.com

Sponsor
Institute Kanagawa children's medical centre
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Knagawa Children's Medical center
Address 2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
Tel 045-711-2351
Email nakajima.13011@kanagawa-pho.jp

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
2016 Year 10 Month 24 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 48
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
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 09 Month 20 Day
Anticipated trial start date
2016 Year 10 Month 24 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 10 Month 01 Day
Date trial data considered complete
2018 Year 10 Month 01 Day
Date analysis concluded
2018 Year 10 Month 06 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 12 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027978

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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