UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019898 |
|---|---|
| Receipt number | R000022983 |
| Scientific Title | Rocuronium-induced withdrawal movements in children associated with different Rocuronium injection method |
| Date of disclosure of the study information | 2015/11/23 |
| Last modified on | 2015/11/23 10:16:17 |
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Basic information
Public title
Rocuronium-induced withdrawal movements in children associated with different Rocuronium injection method
Acronym
Rocuronium-induced withdrawal movements in children associated with different Rocuronium injection method
Scientific Title
Rocuronium-induced withdrawal movements in children associated with different Rocuronium injection method
Scientific Title:Acronym
Rocuronium-induced withdrawal movements in children associated with different Rocuronium injection method
Region
| Japan |
Condition
Condition
Operative pediatric patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives is comparison of pediatrics patients that Rocuronium-induced withdrawal movements associated with different Rocuronium injection method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevention of withdrawal movements
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Intravenous injection fentanyl before undiluted rocuronium
Interventions/Control_2
Intravenous injection dilution of rocuronium
Interventions/Control_3
Intravenous injection fentanyl before diluted rocuronium
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
| 0 | years-old | < |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
body weight is under 20kg
Key exclusion criteria
severe complication
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asaka Watanabe |
Organization
Shizuoka Children's Hospital
Division name
Anesthesiology
Zip code
Address
860 Urusiyama,Aoi-ku,Shizuoka city
TEL
054-247-6251
awminy27@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asaka Watanabe |
Organization
Shizuoka Children's Hospital
Division name
Anesthesiology
Zip code
Address
860 Urusiyama,Aoi-ku,Shizuoka city
TEL
054-247-6251
Homepage URL
awminy27@yahoo.co.jp
Sponsor or person
Institute
Shizuoka Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
静岡県立こども病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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 | 11 | Month | 23 | Day |
Last modified on
| 2015 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022983
