UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024968 |
|---|---|
| Receipt number | R000028727 |
| Scientific Title | Utility of new muscular flaccidity monitorTOFCuff |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2018/07/02 12:46:19 |
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Basic information
Public title
Utility of new muscular flaccidity monitorTOFCuff
Acronym
Utility of TOFCuff
Scientific Title
Utility of new muscular flaccidity monitorTOFCuff
Scientific Title:Acronym
Utility of TOFCuff
Region
| Japan |
Condition
Condition
The operation patient who needs general anesthesia 15 years or older
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Utility of TOFCuff at the time of the general anesthesia operation, monitoring anesthesia maintenance, degree of the line relaxation at the time of the extubation at the time of anesthesia introduction and weigh it against an evaluation in conventional TOF-Watch.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the line relaxation monitoring in TOF-Watch and TOFCuff
Key secondary outcomes
Having or not early post operation respiratory dysfunction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
measuring TOF count before administration of rocuronium
Interventions/Control_2
After administration rocuronium, measuring TOF count or TOF ratio in parallel in TOFCUff and TOF-Watch every 30 seconds
Interventions/Control_3
After the operation, measuring similarly administration of sugammadex
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who it is a state of ASA-PS 1-2, and does not correspond to exclusion criteria
Key exclusion criteria
Patient younger than 15 years
Patient having a neuromuscular disease
Patient having a renal function disorder
Patient having a liver function disorder
Patient thought to be the skin state having difficulty in line relaxation monitoring
The patient whom a study representative or an allotment researcher judged not to be able to evaluate it who it is not cooperative or is enough after a study start during a period until leaving
In addition, the patient who judged that a study representative or an allotment researcher was inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Yamakage |
Organization
Sapporo medical university hospital
Division name
Department of Anesthesiology
Zip code
Address
South 1, West 16 chuo-ku, Sapporo
TEL
011-611-2111
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kazuma |
Organization
Sapporo medical university hospital
Division name
Department of Anesthesiology
Zip code
Address
South 1, West 16 chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
sea_hawk_3104@yahoo.co.jp
Sponsor or person
Institute
Sapporo medical university hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Sapporo medical university hospital, Department of Anesthesiology
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
| 2016 | Year | 11 | Month | 24 | 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
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028727
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
