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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043324
Receipt No. 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 2021/02/14

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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
Email 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
Email doshu.akira@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

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
Email 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
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 Preinitiation
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
2022 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
2021 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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