UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045291 |
|---|---|
| Receipt number | R000051732 |
| Scientific Title | Comparison of Responses of the Little Finger Abductor Muscle and Flexor Hallucis Brevis Muscle from Electromyography-based Neuromuscular Monitors |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/08/28 12:29:10 |
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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
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
hideki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051732
