UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009337 |
|---|---|
| Receipt number | R000010964 |
| Scientific Title | Effect of age and anesthetics on duration of action of rocuronium |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2012/11/15 14:17:10 |
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Basic information
Public title
Effect of age and anesthetics on duration of action of rocuronium
Acronym
duration of action of rocuronium and age
Scientific Title
Effect of age and anesthetics on duration of action of rocuronium
Scientific Title:Acronym
duration of action of rocuronium and age
Region
| Japan |
Condition
Condition
Effect of age and anesthetics on duration of action of rocuronium
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to determine whether duration of individual variability of the action of rocuronium change clinically by patient's age.
Basic objectives2
Others
Basic objectives -Others
Subjects were divided into three groups by age: a young group (< 65 years old), an elderly group (>= 65 years old and < 75 years old) and a very elderly group (>= 75 years old). Duration and individual variability of rocuronium is measured.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration and individual variability of the action of rocuronium change clinically in patients elderly than 75 years old compared with those younger than 75 years.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Young patients whose age are younger than 65 years old.
Interventions/Control_2
Elderly patients whose age are 65-75 years old.
Interventions/Control_3
Very elderly patients whose age are older than 75 years old.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are normal renal and liver functions and body mass index (BMI) between 19 and 28.
Key exclusion criteria
Patients are excluded from the study if they have neuromuscular disease or if they were taking medications known to interact with muscle relaxants.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Takahata |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Takahata |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Homepage URL
osamu@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 15 | Day |
Last modified on
| 2012 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010964
