UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054446 |
|---|---|
| Receipt number | R000062193 |
| Scientific Title | A comparison of electromyographic recovery of the rocuronium-induced neuromuscular block between the adductor pollicis muscle and the flexor hallucis brevis muscle in infants. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/07/21 19:19:40 |
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Basic information
Public title
A comparison of electromyographic recovery of the rocuronium-induced neuromuscular block between the adductor pollicis muscle and the flexor hallucis brevis muscle in infants.
Acronym
A comparison of electromyographic recovery of the rocuronium-induced neuromuscular block between the adductor pollicis muscle and the flexor hallucis brevis muscle in infants.
Scientific Title
A comparison of electromyographic recovery of the rocuronium-induced neuromuscular block between the adductor pollicis muscle and the flexor hallucis brevis muscle in infants.
Scientific Title:Acronym
A comparison of electromyographic recovery of the rocuronium-induced neuromuscular block between the adductor pollicis muscle and the flexor hallucis brevis muscle in infants.
Region
| Japan |
Condition
Condition
Pediatric patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare responses between the adductor pollicis muscle and the flexor hallucis brevis muscle by using TetraGraph during rocuronium-induced neuromuscular block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to reappearance of train-of-four (TOF) count of one.
Key secondary outcomes
Baseline TOF ratio, compound muscle action potential, time to rocuronium administration to TOF count of zero, supramaximal current, time to reappearance of TOF count of 2, time to reappearance of TOF count of 4, final TOF ratio
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Monitoring the adductor pollicis muscle and the flexor hallucis brevis muscle with the same subject.
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
| 1 | months-old | <= |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ASA classification 1-2
Patients consented to participate in this study
Key exclusion criteria
Patients with neuromuscular diseases
Patients with difficult airway
Patients who required 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
Fukuda-Denshi inc.
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 | 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
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062193
