UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044904 |
|---|---|
| Receipt number | R000051290 |
| Scientific Title | A comparison between the adductor pollicis muscle and abductor digiti minimi muscle using Nihon-Kohden electromyography AF-201P in rocuronium-induced neuromuscular block: an observational study |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2022/11/05 09:36:27 |
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Basic information
Public title
A comparison between the adductor pollicis muscle and abductor digiti minimi muscle using Nihon-Kohden electromyography AF-201P in rocuronium-induced neuromuscular block: an observational study
Acronym
A comparison between the adductor pollicis muscle and abductor digiti minimi muscle using Nihon-Kohden electromyography AF-201P in rocuronium-induced neuromuscular block: an observational study
Scientific Title
A comparison between the adductor pollicis muscle and abductor digiti minimi muscle using Nihon-Kohden electromyography AF-201P in rocuronium-induced neuromuscular block: an observational study
Scientific Title:Acronym
A comparison between the adductor pollicis muscle and abductor digiti minimi muscle using Nihon-Kohden electromyography AF-201P in rocuronium-induced neuromuscular block: an observational study
Region
| Japan |
Condition
Condition
Surgical patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare responses between the adductor pollicis muscle and the abductor digiti minimi muscle by using Nihon-Kohden AF201-P during rocuronium-induced neuromuscular block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to reappearance of post tetanic count
Key secondary outcomes
Time to reappearance of train-of four count
Time to reappearance of train-of four count of 2
Recovery time after sugammadex administration
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
Monitoring the adductor pollicis muscle and the abductor digiti minimi muscle with same subject but with different 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 ASA classification 1-3
Patients consented to participate in this study
Key exclusion criteria
Patients having allergic factors to neuromuscular blocking agents and reversal agents
Patients with ASA classification 4-6
Patients with neuromuscular diseases
Patients taking medications that affect the effects of neuromuscular blockade
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Nihon University Itabashi Hospital
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL
0339728111
iwasaki.hajime@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Nihon University Itabashi Hospital
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL
0339728111
Homepage URL
hajime.iwasaki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon-Kohden Inc. Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
+81-3-3972-8111
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 | 07 | Month | 19 | 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 | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
primary outcome: time to
reappearance of post-tetanic count
secondary outcomes: onset time, supramaximal simulation, time to first TOF, time to TOFC=2, time to sugammadex administration to TOFR=90%
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051290
