UMIN-CTR Clinical Trial

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	https://link.springer.com/article/10.1007/s00540-020-02889-2
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00540-020-02889-2
Number of participants that the trial has enrolled	40
Results	Generic rocuronium was considered more suitable than the original rocuronium for induction of anesthesia by propofol performed with a target-controlled infusion system.
Results date posted	2021 Year 04 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	class I or II patients as per American Society of Anesthesiologists
Participant flow	Based on computer-generated randomization charts, patients were randomly divided into two groups, generic rocuronium group (Group G) and original rocuronium group (Group O).
Adverse events	none
Outcome measures	The primary outcome was the total incidence of movement after administration of rocuronium.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 12 Day
Date of IRB	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 02 Month 10 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 04 Day
Last modified on	2021 Year 04 Month 09 Day

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