UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011984 |
|---|---|
| Receipt number | R000014002 |
| Scientific Title | The dilution of roccuronium with saline provide faster onset of neuromuscular blockade. |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2017/05/30 09:58:35 |
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Basic information
Public title
The dilution of roccuronium with saline provide faster onset of neuromuscular blockade.
Acronym
The dilution of roccuronium with saline provide faster onset of neuromuscular blockade.
Scientific Title
The dilution of roccuronium with saline provide faster onset of neuromuscular blockade.
Scientific Title:Acronym
The dilution of roccuronium with saline provide faster onset of neuromuscular blockade.
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 the study is to examine the
influence of dilution of rocuronium with saline on the onset time of neuromuscular blockade
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Monitoring of neuromuscular function with
ulnar nerve stimulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control(injection of undiluted rocuronium 0.9mg/kg)
Interventions/Control_2
injection of dilluted rocuronium(0.9mg/kg)with saline
Interventions/Control_3
injection of undiluted rocuronium 1.2mg/kg
Interventions/Control_4
injection of dilluted rocuronium(1.2mg/kg)with saline
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective surgery under general anesthesia
Key exclusion criteria
allergy to rocuronium
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Myoga |
Organization
Kitakyusyu Municipal Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-1-1 Bashaku, Kokurakita-ku, Kitakyushu 802-0077, JAPAN
TEL
093-522-0383
ikyoku103@kmmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Myoga |
Organization
Kitakyusyu Municipal Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-1-1 Bashaku, Kokurakita-ku, Kitakyushu 802-0077, JAPAN
TEL
093-522-0383
Homepage URL
ikyoku103@kmmc.jp
Sponsor or person
Institute
Kitakyusyu Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kitakyusyu Municipal Medical Center
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
北九州市立医療センター(福岡県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 07 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2017 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014002
