UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043324 |
|---|---|
| Receipt number | R000049407 |
| Scientific Title | The individual variation of the continuous infusion rate of rocuronium calculated by the 4C algorithm body composition analyzer |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2024/02/11 16:29:00 |
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Basic information
Public title
The individual variation of the continuous infusion rate of rocuronium calculated by the 4C algorithm body composition analyzer
Acronym
The individual variation of the continuous infusion rate of rocuronium calculated by the 4C algorithm body composition analyzer
Scientific Title
The individual variation of the continuous infusion rate of rocuronium calculated by the 4C algorithm body composition analyzer
Scientific Title:Acronym
The individual variation of the continuous infusion rate of rocuronium calculated by the 4C algorithm body composition analyzer
Region
| Japan |
Condition
Condition
Patients scheduled for general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating whether individual variabilities of rocuronium can be reduced by determining the dose of rocuronium using the muscle weight calculated by the body composition analyzer equipped with the 4-compartment algorithm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuous infusion rate of rocuronium
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for general anesthesia for more than 3 hours
Key exclusion criteria
similar to traditional muscle relaxant investigations
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Doshu |
| Middle name | Kajiura |
| Last name | Akira |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
doshu.akira@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Doshu |
| Middle name | Kajiura |
| Last name | Akira |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology,
Zip code
1738610
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
Homepage URL
doshu.akira@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
Nihon University School of Medicine
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
Tel
0339728111
komoda.nozomi@nihon-u.ac.jp
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
| 2021 | Year | 02 | Month | 15 | 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
| Delay expected |
Results Delay Reason
ongoing
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigating whether individual variabilities in continuous infusion rate of rocuronium can be minimized by using the body composition measured by the body composition analyzer
Management information
Registered date
| 2021 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049407
| Research Plan | |
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| 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 |
