UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Responses of the Little Finger Abductor Muscle and Flexor Hallucis Brevis Muscle from Electromyography-based Neuromuscular Monitors
Acronym	Comparison of Responses of the Little Finger Abductor Muscle and Flexor Hallucis Brevis Muscle from Electromyography-based Neuromuscular Monitors
Scientific Title	Comparison of Responses of the Little Finger Abductor Muscle and Flexor Hallucis Brevis Muscle from Electromyography-based Neuromuscular Monitors
Scientific Title:Acronym	Comparison of Responses of the Little Finger Abductor Muscle and Flexor Hallucis Brevis Muscle from Electromyography-based Neuromuscular Monitors
Region	Japan

Condition
Condition	Patient undergoing surgery
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the usefulness of electromyography-based muscle relaxation monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence of postoperative respiratory complications
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA PS 1-3 General anesthesia scheduled surgery using muscle relaxants
Key exclusion criteria	Patients with a history of allergy to muscle relaxants or antagonists, ASA PS over 4, BMI of 30 or higher or BMI of 18.5 or lower, patients with neuromuscular diseases, cases with significant hepatic dysfunction, patients with an implanted cardiac pacemaker or implantable cardioverter defibrillator (ICD), pregnant women and patients who may be pregnant and others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kae Middle name Last name Hino
Organization	Kawasaki Medical School
Division name	Anesthesiology and Intensive Care Medicine
Zip code	701-0192
Address	577 Matsushima, Kurashiki City, Okayama Prefecture
TEL	0864621111
Email	ikek1109@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Nakatsuka
Organization	Kawasaki Medical School
Division name	Anesthesiology and Intensive Care Medicine
Zip code	701-0192
Address	577 Matsushima, Kurashiki City, Okayama Prefecture
TEL	0864621111
Homepage URL
Email	hideki@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
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	Kawasaki Medical School
Address	577 Matsushima, Kurashiki City, Okayama Prefecture
Tel	0864621111
Email	ikek1109@med.kawasaki-m.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 10 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	Preinitiation
Date of protocol fixation	2021 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	EMG electrodes for muscle relaxation monitoring are attached to the hand (abductor hallucis longus) and foot (flexor digitorum brevis), and after induction of general anesthesia, stimulation is performed in TOF continuous mode and the results of each are recorded.

Management information
Registered date	2021 Year 08 Month 28 Day
Last modified on	2021 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051732