UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012992 |
|---|---|
| Receipt number | R000015171 |
| Scientific Title | Duration of rocuronium-induced neuromuscular block under total intravenous aneshtesia in pediatric patient |
| Date of disclosure of the study information | 2014/01/28 |
| Last modified on | 2014/01/28 16:28:45 |
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Basic information
Public title
Duration of rocuronium-induced neuromuscular block under total intravenous aneshtesia in pediatric patient
Acronym
Duration of rocuronium-induced neuromuscular block under total intravenous aneshtesia in pediatric patient
Scientific Title
Duration of rocuronium-induced neuromuscular block under total intravenous aneshtesia in pediatric patient
Scientific Title:Acronym
Duration of rocuronium-induced neuromuscular block under total intravenous aneshtesia in pediatric patient
Region
| Japan |
Condition
Condition
Surgical pediatric patients requiring general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate that duration of rocuronium induced neuromusclar blockade for pediatric patient under total venous aneshtesia by accelermyographically monitor.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery time of T1 to 10% after single administration of rocuronium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients will recive sugammadex 2mg/kg when train of four(TOF) 2/4.
Interventions/Control_2
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
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 12 years old and below
2) ASA risk classification 1 and 2
3) Patients consented to participate in this study
Key exclusion criteria
1)Patients having allergic factors to neuromuscular blocking agents
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norifumi Kuratani |
Organization
Saitama children's medical center
Division name
Department of Anesthesiology
Zip code
Address
2100 Magome, Iwatsuki, Saitama 339-8551, Japan
TEL
+81-48-758-1811
norimd@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sekijima Chihiro |
Organization
Saitama Children's medical center
Division name
Department of anesthesiology
Zip code
Address
2100 Magome, Iwatsuki, Saitama 339-8551, Japan
TEL
+81-48-758-1811
Homepage URL
sekijima.chihiro@pref.saitama.lg.jp
Sponsor or person
Institute
Saitama Children's medical center Department of aneshtesiology
Institute
Department
Personal name
Funding Source
Organization
Departmental funding
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
| 2014 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2014 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015171
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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