UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacodynamic model of rocuronium in patients with muscle relaxation: comparison of electromyography-based and acceleromyography-based neuromuscular monitoring
Acronym	Pharmacodynamic modeling of rocuronium in patients with general anesthesia
Scientific Title	Pharmacodynamic model of rocuronium in patients with muscle relaxation: comparison of electromyography-based and acceleromyography-based neuromuscular monitoring
Scientific Title:Acronym	Pharmacodynamic modeling of rocuronium in patients with general anesthesia
Region	Japan

Condition
Condition	Patients scheduled for surgery under general anesthesia that requires neuromuscular blockade only for intubation
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of pharmacodynamic model of rocuronium in patients with muscular blockade using electromyography-based and acceleromyography-based neuromuscular monitoring
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacodynamic model of rocuronium in patients with deep muscular blockade using electromyography-based and acceleromyography-based neuromuscular monitoring
Key secondary outcomes	(1) Difference in rocuronium pharmacodynamic models between electromyography-based and acceleromyography-based neuromuscular monitoring (2) Pharmacodynamic parameters of rocuronium (3) Relationship between effect-site concentration and neuromuscular effect (4) Difference in effect-site concentration for between the concentration of rocuronium effective site for electromyography-based and acceleromyography-based neuromuscular monitoring

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use of electromyography-based and acceleromyography-based neuromuscular monitors, simultaneously during general anesthesia
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient scheduled for elective surgery that requires neuromuscular blockade only for anesthesia induction
Key exclusion criteria	Patients with severe hepatic, renal, or cardiovascular disease, neuromuscular disease, a history of rocuronium allergy, body mass index greater than 35 kg/m2
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Masui
Organization	Showa University School of Medicine
Division name	Department of Anesthesiology
Zip code	142-8666
Address	Hatanodai 1-5-8, Shinagawa, Tokyo
TEL	03-3784-8575
Email	kenichi@masuinet.com

Public contact
Name of contact person	1st name Kenichi Middle name Last name Masui
Organization	Showa University School of Medicine
Division name	Department of Anesthesiology
Zip code	142-8666
Address	Hatanodai 1-5-8, Shinagawa, Tokyo
TEL	03-3784-8575
Homepage URL
Email	kenichi@masuinet.com

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Showa University
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	Showa University
Address	Hatanodai 1-5-8, Shinagawa, Tokyo
Tel	03-3784-8000
Email	m-rinri@ofc.showa-u.ac.jp

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	2021 Year 05 Month 23 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	2021 Year 03 Month 01 Day
Date of IRB	2021 Year 01 Month 08 Day
Anticipated trial start date	2021 Year 05 Month 24 Day
Last follow-up date	2022 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	2021 Year 05 Month 23 Day
Last modified on	2022 Year 11 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050603