UMIN-CTR Clinical Trial

Basic information
Public title	Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Acronym	Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Scientific Title	Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Scientific Title:Acronym	Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Region	Japan

Condition
Condition	patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Our hypothesis is that dilution of rocuronium bromide with 0.9% saline (increased volume, same dosage) can change its distribution and consiquently make onset time faster than undiluted solution.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset time of neuromuscular blockade
Key secondary outcomes	Duration 25% (time from the start of injection of NMBA until the T1 in the TOF or the single twitch has recovered to 25% of the final value), Duration TOF 0.9 (the time from start of injection of the NMBA until recovery of the TOF ratio to 0.9), rocuronium-induced withdrawal movement

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Group 1 receive undiluted rocuronium 0.6 mg kg-1 over 5 seconds
Interventions/Control_2	Group 2 receive diluted rosuronium 0.6 mg kg-1 in 20 ml 0.9% saline over 5 seconds
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with an ASA physical status 1 or 2, scheduled for elective surgery under general anesthesia using rocuronium and supraglottic device at the Ryukyu university hospital are recruited.
Key exclusion criteria	Patients with severe hepatic, renal, or cardiovascular disease, neuromuscular disease, a history of rocuronium allergy, body mass index >=25 kg/m2 were excluded.
Target sample size	106

Research contact person
Name of lead principal investigator	1st name Middle name Last name Misuzu Hayashi
Organization	Ryukyu university hospital
Division name	Department of anesthesiology
Zip code
Address	Uehara 207, Nishihara, Nakagami, Okinawa 903-0125
TEL	098-895-1336
Email	koba_shu1982@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Misuzu Hayashi
Organization	Ryukyu university hospital
Division name	Department of anesthesiology
Zip code
Address	Uehara 207, Nishihara, Nakagami, Okinawa 903-0125
TEL	098-895-1336
Homepage URL
Email	koba_shu1982@yahoo.co.jp

Sponsor
Institute	Ryukyu university
Institute
Department

Funding Source
Organization	nothing
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 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	Terminated
Date of protocol fixation	2016 Year 06 Month 28 Day
Date of IRB	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 30 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026818