UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051162 |
|---|---|
| Receipt number | R000058336 |
| Scientific Title | A comparison of supramaximal current for monitoring adductor pollicis muscle between acceleromyography and electromyography in pediatric patients |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/05/19 07:39:16 |
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Basic information
Public title
A comparison of supramaximal current for monitoring adductor pollicis muscle between acceleromyography and electromyography in pediatric patients
Acronym
A comparison of supramaximal current for monitoring adductor pollicis muscle between acceleromyography and electromyography in pediatric patients
Scientific Title
A comparison of supramaximal current for monitoring adductor pollicis muscle between acceleromyography and electromyography in pediatric patients
Scientific Title:Acronym
A comparison of supramaximal current for monitoring adductor pollicis muscle between acceleromyography and electromyography in pediatric patients
Region
| Japan |
Condition
Condition
Pediatric patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison of supramaximal current between AMG and EMG in pediatric aptients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Supramaximal current after calibration with each devices.
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using both AMG and EMG
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
| 2 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients undergoing general anesthesia.
ASA physical status 1 or 2
Key exclusion criteria
Patient with neuromuscular disease
Patient with difficult airway
Patient who require rapid sequence induction
Target sample size
25
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 and Critical Care Medicine
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-Khoden
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
| 2023 | Year | 06 | Month | 01 | 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
25
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
Main results already published
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058336
