UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044298 |
|---|---|
| Receipt number | R000050603 |
| Scientific Title | Pharmacodynamic model of rocuronium in patients with muscle relaxation: comparison of electromyography-based and acceleromyography-based neuromuscular monitoring |
| Date of disclosure of the study information | 2021/05/23 |
| Last modified on | 2022/11/23 12:51:43 |
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Basic information
Public title
Pharmacodynamic model of rocuronium in patients with muscle relaxation: comparison of electromyography-based and acceleromyography-based neuromuscular monitoring
Acronym
Pharmacodynamic modeling of rocuronium in patients with general anesthesia
Scientific Title
Pharmacodynamic model of rocuronium in patients with muscle relaxation: comparison of electromyography-based and acceleromyography-based neuromuscular monitoring
Scientific Title:Acronym
Pharmacodynamic modeling of rocuronium in patients with general anesthesia
Region
| Japan |
Condition
Condition
Patients scheduled for surgery under general anesthesia that requires neuromuscular blockade only for intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of pharmacodynamic model of rocuronium in patients with muscular blockade using electromyography-based and acceleromyography-based neuromuscular monitoring
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacodynamic model of rocuronium in patients with deep muscular blockade using electromyography-based and acceleromyography-based neuromuscular monitoring
Key secondary outcomes
(1) Difference in rocuronium pharmacodynamic models between electromyography-based and acceleromyography-based neuromuscular monitoring
(2) Pharmacodynamic parameters of rocuronium
(3) Relationship between effect-site concentration and neuromuscular effect
(4) Difference in effect-site concentration for between the concentration of rocuronium effective site for electromyography-based and acceleromyography-based neuromuscular monitoring
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of electromyography-based and acceleromyography-based neuromuscular monitors, simultaneously during general anesthesia
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
Patient scheduled for elective surgery that requires neuromuscular blockade only for anesthesia induction
Key exclusion criteria
Patients with severe hepatic, renal, or cardiovascular disease, neuromuscular disease, a history of rocuronium allergy, body mass index greater than 35 kg/m2
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology
Zip code
142-8666
Address
Hatanodai 1-5-8, Shinagawa, Tokyo
TEL
03-3784-8575
kenichi@masuinet.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology
Zip code
142-8666
Address
Hatanodai 1-5-8, Shinagawa, Tokyo
TEL
03-3784-8575
Homepage URL
kenichi@masuinet.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University
Address
Hatanodai 1-5-8, Shinagawa, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-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 | 05 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050603
