UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007276 |
|---|---|
| Receipt number | R000008545 |
| Scientific Title | Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2020/08/20 21:28:31 |
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Basic information
Public title
Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Acronym
Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Scientific Title
Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Scientific Title:Acronym
Determination of optimal neuromuscular reversal dose of Sugammadex in pediatric patients
Region
| Japan |
Condition
Condition
Surgical pediatric patients undergoing general anesthesia
Classification by specialty
| Surgery in general | Ophthalmology | Oto-rhino-laryngology |
| Orthopedics | Urology | Anesthesiology |
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the necessity of additional Sugammadex in a short post-operative period.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It is possible to determine the necessity of additional Sugammadex for the complete reversal of neuromuscular block in a short post-operative period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sufficient group
Interventions/Control_2
insufficient group
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
| 0 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
surgical pediatric patients undergoing general anesthesia
Key exclusion criteria
1.patients with liver and renal dysfunction
2.patients with neuromuscular disease
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Iwasaki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and critical care medicine
Zip code
Address
higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL
0166682583
iwasakih@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Iwasaki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and critical care medicine
Zip code
Address
higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL
0166682583
Homepage URL
iwasakih@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
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
| 2012 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008545
