UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019128 |
|---|---|
| Receipt number | R000022114 |
| Scientific Title | Efficacy of premedication with Kan-baku-taiso-to on postoperative agitation in pediatric ophthalmic surgery |
| Date of disclosure of the study information | 2015/09/27 |
| Last modified on | 2015/09/27 17:30:49 |
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Basic information
Public title
Efficacy of premedication with Kan-baku-taiso-to on postoperative agitation in pediatric ophthalmic surgery
Acronym
Efficacy of Kan-baku-taiso-to on postoperative agitation
Scientific Title
Efficacy of premedication with Kan-baku-taiso-to on postoperative agitation in pediatric ophthalmic surgery
Scientific Title:Acronym
Efficacy of Kan-baku-taiso-to on postoperative agitation
Region
| Japan |
Condition
Condition
Pediatric patients who undergo ophthalmic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Kan-baku-taiso-to on postoperative agitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative agitation
Nausea
Vomitting
Antiemetic drug
Key secondary outcomes
Postoperative pain
Postoperative analgesics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative administration of Kan-baku-taiso-to
Interventions/Control_2
Preoperative administration of none
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
| 4 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients who undergo ophthalmic surgery
Key exclusion criteria
Patients with congential malformation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka medical college
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi Takatsuki city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi Majima |
Organization
Osaka medical college
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi Takatsuki city
TEL
0726-84-6361
Homepage URL
majima393@yahoo.co.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Osakamedical College
Tsumura
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
大阪医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 27 | 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
| 2015 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | 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
| 2015 | Year | 09 | Month | 27 | Day |
Last modified on
| 2015 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022114
