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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030677
Receipt No. R000035023
Scientific Title Comparison of injection pain between original and generic rocuronium
Date of disclosure of the study information 2018/01/05
Last modified on 2018/07/23

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Basic information
Public title Comparison of injection pain between original and generic rocuronium
Acronym Comparison of original and generic rocuronium
on injection pain
Scientific Title Comparison of injection pain between original and generic rocuronium
Scientific Title:Acronym Comparison of original and generic rocuronium
on injection pain
Region
Japan

Condition
Condition Patients undergoing operations under general anesthesia, not limited to specific diseases
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The incidence of rocuronium injection pain has been reported. It has been suggested that generic rocuronium, which has glycine as one of the buffer materials, can reduce injection pain on study in rats. Our objective is to compare injection pain caused by between original and generic rocuronium in patients undergoing operations under general anesthesia.
Basic objectives2 Others
Basic objectives -Others To verify the efficacy and the degree of side reactions
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Movement of the extremities after injecting rocuronium
Perfusion index
Changes of vital signs
Key secondary outcomes Efficacy and the degree of side reactions of rocuronium

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We inject generic rocuronium 0.9 mg/kg into a vein after induction of general anesthesia with propofol or thiamylal.
Interventions/Control_2 We inject original rocuronium 0.9 mg/kg into a vein after induction of general anesthesia with propofol or thiamylal.
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 who undergo operations under general anesthesia
Key exclusion criteria Patient with allergy of rocuronium, propofol and thiamyral
Patients with neuromuscular disease
Obesity patients (BMI 35 or higher)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunobu Takahashi
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address S1 W17, Chuo-ku, Sapporo,Hokkaido, 060-8556, Japan
TEL +81-11-611-2111
Email takahashi.k@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunobu Takahashi
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address S1 W17, Chuo-ku, Sapporo,Hokkaido, 060-8556, Japan
TEL +81-11-611-2111
Homepage URL
Email takahashi.k@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 05 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 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
2018 Year 01 Month 04 Day
Last modified on
2018 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035023

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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