UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054036 |
|---|---|
| Receipt number | R000061690 |
| Scientific Title | The impact of obesity in electromyographic neuromuscular monitoring. |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2024/10/02 09:32:36 |
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Basic information
Public title
The impact of obesity in electromyographic neuromuscular monitoring.
Acronym
The impact of obesity in electromyographic neuromuscular monitoring.
Scientific Title
The impact of obesity in electromyographic neuromuscular monitoring.
Scientific Title:Acronym
The impact of obesity in electromyographic neuromuscular monitoring.
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to demonstrate the impact of obesity on electromyographic neuromuscular monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Supramaximal current
Key secondary outcomes
compound muscle action potential, impossible measurement, distance from skin surface to abductor digiti minimi muscle, distance from skin surface to ulnar nerve, baseline TOF ratio, final TOF ratio
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with BMI > 30 and BMI 18.5-24.9
Key exclusion criteria
Patient with neuromuscular disease, patient with ASA 4, 5, 6 (except obesity)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
iwasakih@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Homepage URL
iwasakih@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Nihon-Kohden
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2187
sho-kenkyu@jimu.asahikawa-med.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
| 2024 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2027 | 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: supramaximal current
Management information
Registered date
| 2024 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061690
