UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017884 |
|---|---|
| Receipt number | R000020718 |
| Scientific Title | Correlation between duration of rocuronium and muscle mass. |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2015/06/13 23:49:15 |
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Basic information
Public title
Correlation between duration of rocuronium and muscle mass.
Acronym
Correlation between duration of rocuronium and muscle mass.
Scientific Title
Correlation between duration of rocuronium and muscle mass.
Scientific Title:Acronym
Correlation between duration of rocuronium and muscle mass.
Region
| Japan |
Condition
Condition
Patients undergoing elective surgery under general anesthesia in the supine position.
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The principal aim of this study is to analyze the correlation between duration of rocuronium and muscle mass.
Basic objectives2
Others
Basic objectives -Others
The aim of study is to verify that duration of individual variability of the action of rocuronium attribute to muscle mass of the individual.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Recovery time of T1 to 10% and 25% after single administration of rocuronium.
mascle mass.
lean body weight.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients consented to participate in this study.
ASA risk classification 1 and 2 and 3.
Key exclusion criteria
Emergency surgery cases, cases of heart failure, cases of neuromuscular disease, cases of local anesthetic use example of the limbs, anticonvulsants oral cases, renal dysfunction cases, severe hepatic dysfunction cases and pacemaker use cases are excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
072-683-1221
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Hattori |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
072-683-1221
Homepage URL
rsg39649@gmail.com
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
| 2015 | Year | 06 | Month | 12 | 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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between duration of rocuronium and muscle mass.
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2015 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020718
