UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of the different electromyography-based neuromuscular monitor, the AF-201P and the TetraGraph, in rocuronium-induced neuromuscular block: A prospective comparative study
Acronym	A comparison of AF201-P and TetraGraph
Scientific Title	A comparison of the different electromyography-based neuromuscular monitor, the AF-201P and the TetraGraph, in rocuronium-induced neuromuscular block: A prospective comparative study
Scientific Title:Acronym	A comparison of AF201-P and TetraGraph
Region	Japan

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

Objectives
Narrative objectives1	The aim of the study was to compare the responses obtained simultaneously from the new developed electromyography (EMG)-based neuromuscular monitor, the AF-201P and the TetraGraph, during rocuronium-induced neuromuscular block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The time from administration of rocuronium to first appearance of PTC response
Key secondary outcomes	The supramaximal current, baseline compound action potential, time from administration of rocuronium to TOFC0 (onset time), time from administration of rocuronium to first reappearance of TOFC1 (time to TOFC1), time from administration of rocuronium to first reappearance of TOFC2 (time to TOFC2), and time from administration of sugammadex to TOF ratio 90% or higher

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The AF-201P was placed on the right or left arm. TetraGraph was then placed on the contralateral arm.
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	Patients with American Society of Anesthesiologists physical status classification 1-3. After receiving written informed consent, patients aged twenty years old or more undergoing surgery with general anesthesia.
Key exclusion criteria	Patients with American Society of Anesthesiologists physical status classification 4 or more, patients with a history of allergic reaction to NMBAs, patients with hepatic disease, patients with neuromuscular disease, and patients who were receiving medication known to interfere with neuromuscular function.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hanae Middle name Last name Sato
Organization	Nihon University Itabashi Hospital
Division name	Department of Anesthesiology
Zip code	1738610
Address	30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL	0339728111
Email	nakamura.hanae@nihon-u.ac.jp

Public contact
Name of contact person	1st name Hanae Middle name Last name Sato
Organization	Nihon University Itabashi Hospital
Division name	Department of Anesthesiology
Zip code	1738610
Address	30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL	0339728111
Homepage URL
Email	nakamura.hanae@nihon-u.ac.jp

Sponsor
Institute	Nihon University Itabashi Hospital Department of Anesthesiology
Institute
Department

Funding Source
Organization	Nihon University Itabashi Hospital Department of Anesthesiology
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	Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address	30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
Tel	0339728111
Email	komoda.nozomi@nihon-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 06 Month 22 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	20
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	Completed
Date of protocol fixation	2021 Year 06 Month 21 Day
Date of IRB	2021 Year 06 Month 11 Day
Anticipated trial start date	2021 Year 06 Month 22 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The aim of the study was to compare the responses obtained simultaneously from the new developed electromyography (EMG)-based neuromuscular monitor, the AF-201P and the TetraGraph, during rocuronium-induced neuromuscular block.

Management information
Registered date	2021 Year 06 Month 22 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050927