UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037050 |
|---|---|
| Receipt number | R000039129 |
| Scientific Title | A comparative double-blind study on response between electromyography-type and acceleromyography-type neuromuscular monitor in the state of muscle relaxation by rocuronium |
| Date of disclosure of the study information | 2019/06/13 |
| Last modified on | 2022/12/18 10:53:16 |
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Basic information
Public title
A comparative double-blind study on response between electromyography-type and acceleromyography-type neuromuscular monitor in the state of muscle relaxation by rocuronium
Acronym
Comparison of electromyography-type and acceleromyography-type neuromuscular monitor
Scientific Title
A comparative double-blind study on response between electromyography-type and acceleromyography-type neuromuscular monitor in the state of muscle relaxation by rocuronium
Scientific Title:Acronym
Comparison of electromyography-type and acceleromyography-type neuromuscular monitor
Region
| Japan |
Condition
Condition
patient undergoing surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare measured values of electromyography and acceleromyography-type neuromuscular monitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between measured response of electromyography-type and acceleromyography-type neuromuscular monitor
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient undergoing surgery with muscle relaxant
Key exclusion criteria
patients with neuromuscular disorder
high risk patients ASA PS >3
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Nakatsuka |
Organization
Kawasaki Medical School
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
701-0192
Address
577 Matsushima
TEL
086-462-1111
hideki@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
Department of Anesthesiology and Intensive Care Medicine
Zip code
701-0192
Address
577 Matsushima
TEL
086-462-1111
Homepage URL
hideki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Anesthesiology & Intensive Care Medicine
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
Ethics Committee
Tel
086-462-1111
gsweb@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
| 2019 | Year | 06 | Month | 13 | 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
| Delay expected |
Results Delay Reason
Prior to the multi-center study with the same purpose limited to anesthesia, there are not enough cases in this study.
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
| 2019 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to compare clinical standard when muscle relaxants and antagonists are used by comparing measured values of AF-201P (Nihon Kohden Corporation) and TOF Watch (Nihon Kohden Corporation).
Management information
Registered date
| 2019 | Year | 06 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039129
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/12/18 | 02_kenkyujissi_keikakusyo（研究計画書20220627筋弛緩）.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
