UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026687 |
|---|---|
| Receipt number | R000030591 |
| Scientific Title | The effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients |
| Date of disclosure of the study information | 2017/03/28 |
| Last modified on | 2017/03/23 14:39:30 |
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Basic information
Public title
The effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients
Acronym
The effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients
Scientific Title
The effect of Yokukansan suppository to prevent emergence agitation after general anesthesia in pediatric patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ka Koui |
Organization
Kanagawa children's medical centre
Division name
Department of Anesthesiology
Zip code
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
TEL
045-711-2351
kka@kcmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ka Koui |
Organization
Kanagawa children's medical centre
Division name
Department of Anesthesiology
Zip code
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan
TEL
045-711-2351
Homepage URL
kka@kcmc.jp
Sponsor or person
Institute
Kanagawa children's medical centre
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 23 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030591
