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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026737
Receipt No. R000030695
Scientific Title The Effect of dilute administration of rocuronium on vascular pain and muscle relaxant onset time
Date of disclosure of the study information 2017/03/29
Last modified on 2017/09/28

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Basic information
Public title The Effect of dilute administration of rocuronium on
vascular pain and muscle relaxant onset time
Acronym The Effect of dilute administration of rocuronium on
vascular pain and muscle relaxant onset time
Scientific Title The Effect of dilute administration of rocuronium on
vascular pain and muscle relaxant onset time
Scientific Title:Acronym The Effect of dilute administration of rocuronium on
vascular pain and muscle relaxant onset time
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of dilute administration of rocuronium on vascular pain and muscle relaxant action onset time
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Vascular pain
2) Muscle relaxant onset time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Use raw solution rocuronium
Interventions/Control_2 Use half diluted rocuronium
Interventions/Control_3 Use one third diluted rocuronium
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
80 years-old >
Gender Male and Female
Key inclusion criteria Healthy Adults
Key exclusion criteria Patient with allergy of rocuronium
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Harada
Organization Aichi Gakuin University School of Dentistry
Division name Department of Anesthesiology
Zip code
Address 2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL 052-759-2111
Email hjun@dpc.agu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiji Sato(Boku)
Organization Aichi Gakuin University School of Dentistry
Division name Department of Anesthesiology
Zip code
Address 2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL 052-759-2111
Homepage URL
Email bokuaiji@dpc.agu.ac.jp

Sponsor
Institute Aichi Gakuin University School of Dentistry
Institute
Department

Funding Source
Organization Aichi Gakuin University School of Dentistry
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 愛知学院大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 29 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
2017 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030695

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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