UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The dilution of roccuronium with saline provide faster onset of neuromuscular blockade.
Title of the study (Brief title)	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	Yoshinori Myoga
Organization	Kitakyusyu Municipal Medical Center
Division name	Department of Anesthesiology
Address	2-1-1 Bashaku, Kokurakita-ku, Kitakyushu 802-0077, JAPAN
TEL	093-522-0383
Email	ikyoku103@kmmc.jp

Public contact
Name of contact person	Yoshinori Myoga
Organization	Kitakyusyu Municipal Medical Center
Division name	Department of Anesthesiology
Address	2-1-1 Bashaku, Kokurakita-ku, Kitakyushu 802-0077, JAPAN
TEL	093-522-0383
Homepage URL
Email	ikyoku103@kmmc.jp

Sponsor
Institute	Kitakyusyu Municipal Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014002