UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052360 |
|---|---|
| Receipt number | R000059777 |
| Scientific Title | A Retrospective Study of Prediction of Posttetanic Counts in Electromyography-based Neuromuscular Monitor |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2024/01/15 16:20:17 |
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Basic information
Public title
A Retrospective Study of Prediction of Posttetanic Counts in Electromyography-based Neuromuscular Monitor
Acronym
Prediction of PTC counts in EMG-based neuromuscular monitor
Scientific Title
A Retrospective Study of Prediction of Posttetanic Counts in Electromyography-based Neuromuscular Monitor
Scientific Title:Acronym
Prediction of PTC counts in EMG-based neuromuscular monitor
Region
| Japan |
Condition
Condition
patients undergoing general anesthesia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective study to predict post-tetanic counting results with electromyography-based neuromuscular monitor in the presence of electrical noise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the result of post-tetanic count and the action potential amplitude of the first response after tetanic stimulation is examined.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia with an electromyographic muscle relaxation monitor, in whom the results of post-tetanic counting and the first potential after tetanus stimulation were recorded
Key exclusion criteria
Patients with severe cardiac, hepatic, renal, or neuromuscular diseases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hashimoto |
Organization
Meitetsu Hospital
Division name
Anesthesiology
Zip code
4518511
Address
2-26-11, Sako, Nishi-ku, Nagoya
TEL
052-551-6121
mydiscovery98@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hashimoto |
Organization
Meitetsu Hospital
Division name
Anesthesiology
Zip code
4518511
Address
2-26-11, Sako, Nishi-ku, Nagoya
TEL
052-551-6121
Homepage URL
mydiscovery98@gmail.com
Sponsor or person
Institute
Meitetsu Hospital
Institute
Department
Personal name
Atsushi Hashimoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meitetsu Hospital Ethics Comittee
Address
2-26-11, Sako, Nishi-ku, Nagoya
Tel
052-551-6121
mydiscovery98@gmail.com
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 | 10 | Month | 10 | 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
11
Results
In individual patients, there was observed a correlation between the first response potential (V1) following tetanic stimulation and post-tetanic count. However, when considering the entire patient cohort collectively, the correlation diminished.
Results date posted
| 2024 | Year | 01 | Month | 15 | Day |
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 | 09 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 15 | Day |
Other
Other related information
The relationship between posttetanic counts and the first potential after tetanus stimulation in retrospectively are compared.
Management information
Registered date
| 2023 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
