UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034996 |
|---|---|
| Receipt number | R000039747 |
| Scientific Title | Comparison of Responses of Electromyogram and Acceleromyogram Neuromuscular Monitoring in Deep Muscle Relaxation by rocuronium, open-label, multicenter study |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2023/12/26 08:55:13 |
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Basic information
Public title
Comparison of Responses of Electromyogram and Acceleromyogram Neuromuscular Monitoring in Deep Muscle Relaxation by rocuronium, open-label, multicenter study
Acronym
Comparison of Responses of EMG and AMG Neuromuscular Monitoring in Deep Muscle Relaxation
Scientific Title
Comparison of Responses of Electromyogram and Acceleromyogram Neuromuscular Monitoring in Deep Muscle Relaxation by rocuronium, open-label, multicenter study
Scientific Title:Acronym
Comparison of Responses of EMG and AMG Neuromuscular Monitoring in Deep Muscle Relaxation
Region
| Japan |
Condition
Condition
Patients undergoing surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to compare clinical standard compatibility when muscle relaxants and antagonists are used by comparing measured values of AF-201P (Nihon Kohden Corporation) and TOF Watch(Nihon Kohden Corporation).
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time from rocuronium administration to first appearance of post-tetanic counts (min)
Key secondary outcomes
Time course of post-tetanic counts values
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
Patients undergoing surgery under general anesthesia using rocuronium as neuromuscular blocking agent.
ASA physical status1-3.
Key exclusion criteria
Patients who have a history of allergies to muscle relaxants or antagonists
Case of severe systemic complications
Obesity patients with BMI 30 or more and low body weight patients below 18.5
Patients with neuromuscular disease
Case with significant liver dysfunction
Patient who has cardiac pacemaker, implantable cardioverter defibrillator (ICD) in place
Pregnant women, patients who may be pregnant
Others who judged that the research director is inappropriate as the research subject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Takagi |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
takagi.shunichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | takagi |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
takagi.shunichi@nihon-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Itabashi Hospital, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Asahikawa Medical University Hospital
Department of Anesthesiology, Toho University Ohashi Medical Center
Department of Anesthesiology, Kagoshima Medical Association Hospital
Department of Anesthesiology, Kawasaki Medical School Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itabashi Hospital, Nihon University School of Medicine
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
Tel
0339728111
shunichi.takagi@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
旭川医科大学病院（北海道）、東邦大学大橋病院（東京都）、鹿児島市医師会病院（鹿児島県）、川崎医科大学付属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 26 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 compatibility 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
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039747
