UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the reduced injection pain of the newly developed formation of the rocuronium
Title of the study (Brief title)	Assessment of injection pain of rocuronium
Region	Japan

Condition
Condition	Patients requiring general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will investigate injection associated pain will be reduced in newly developed formula of roculonium, comparing to the eslax, currently available formula of roculonium. Primary outcome will be a frequency of the withdrawal response of upper arm 3 minutes after the drug injection. Secondary outcomes will be the magnitude of the withdrawal response, change of blood pressure and heart rate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	frequency of the withdrawal response of upper arm 3 minutes after the drug injection.
Key secondary outcomes	magnitude of the withdrawal response, change of blood pressure and heart rate 3 minutes after the drug injection.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) 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	After the induction of general anesthesia, newly developed form of roculonium (0.9mg/Kg) will be injected intravenously.
Interventions/Control_2	After the induction of general anesthesia, eslax (0.9mg/Kg) will be injected intravenously.
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	1 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who will receive elective surgery under general anesthesia and obtained written informed consent about this study.
Key exclusion criteria	Muscular disease Known allergy against eslax, propofol Muscle weakness of upper arm Obesity (BMI>30%)
Target sample size	150

Research contact person
Name of lead principal investigator	Fumimasa Amaya
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Anesthesiology
Address	Kajiicho 465 Kamigyo-ku Kyoto
TEL	075-251-5633
Email	ama@koto.kpu-m.ac.jp

Public contact
Name of contact person	Fumimasa Amaya
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Anesthesiology
Address	Kajiicho 465 Kamigyo-ku Kyoto
TEL	075-251-5633
Homepage URL
Email	ama@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Maruishi Pharmaceutical Co.Ltd Fuji Phrama Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2016 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 11 Day
Anticipated trial start date	2017 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 13 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025693