UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023351 |
|---|---|
| Receipt number | R000026907 |
| Scientific Title | Neuromuscular block required for prevention of foot movement during transurethral resection of the bladder tumor under general anesthesia |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2018/02/05 08:55:05 |
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Basic information
Public title
Neuromuscular block required for prevention of foot movement during transurethral resection of the bladder tumor under general anesthesia
Acronym
Sufficient neuromuscular block for TUR-Bt
Scientific Title
Neuromuscular block required for prevention of foot movement during transurethral resection of the bladder tumor under general anesthesia
Scientific Title:Acronym
Sufficient neuromuscular block for TUR-Bt
Region
| Japan |
Condition
Condition
Patients undergoing elective transurethral resection of the bladder tumor under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the dosage of neuromuscular blocking agents and the degree of neuromuscular block recuired for prevention of foot movement during transurethral resection of the bladder tumor under general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The neuromuscular blocking agent is administrated dividedly. When the foot movement caused by stimulation of obturator nerve is disappeared, the cumulative dose of that is recorded.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elective transurethral resection of the bladder tumor under general anesthesia,
Key exclusion criteria
severe coagulopathy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Yamamoto |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Anesthesiology
Zip code
Address
Kumamoto University Hospital, 1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan, 860-8556
TEL
096-373-5275
yamyam@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Fujimoto |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Anesthesiology
Zip code
Address
Kumamoto University Hospital, 1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan, 860-8556
TEL
096-373-5275
Homepage URL
mfujimoto-kmm@umin.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/aas.13045/full
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
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The neuromuscular blocking agent is administrated dividedly. When the foot movement caused by stimulation of obturator nerve is disappeared, the cumulative dose of that is recorded.
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026907
