UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006766 |
|---|---|
| Receipt number | R000008006 |
| Scientific Title | Correlation between patient's factors and the effect of rocuronium and sugammadex |
| Date of disclosure of the study information | 2011/11/24 |
| Last modified on | 2017/11/29 11:10:49 |
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Basic information
Public title
Correlation between patient's factors and the effect of rocuronium and sugammadex
Acronym
Correlation between patient's factors and the effect of rocuronium and sugammadex
Scientific Title
Correlation between patient's factors and the effect of rocuronium and sugammadex
Scientific Title:Acronym
Correlation between patient's factors and the effect of rocuronium and sugammadex
Region
| Japan |
Condition
Condition
Patients undergoing surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to inestigate the correlation between patient's factors and the effect of rocuronium and sugammadex.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monitoring of neuromuscular function by train of four stimulation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing surgery under general anesthesia
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Fujimoto |
Organization
Graduate school of Medical Science, Kumamoto University
Division name
Department of Anesthesiology
Zip code
Address
1-1-1, Honjyo, Kumamoto-City, Kumamoto, Japan
TEL
096-373-5275
mfujimoto-kmm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Fujimoto |
Organization
Graduate school of Medical Science, Kumamoto University
Division name
Department of Anesthesiology
Zip code
Address
1-1-1, Honjyo, Kumamoto-City, Kumamoto, Japan
TEL
096-373-5275
Homepage URL
mfujimoto-kmm@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Graduate school of Medical Science, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2011 | 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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The correlation between patient's backgrounds (age, sex, height, weight, body mass index, laboratory data and previous illness) and the effect of rocuronium (onset time and duration time) or recovery time of rocuronium-induced neuromuscular block after reversal with sugammadex are investigated prospectively.
Management information
Registered date
| 2011 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008006
