UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025004 |
|---|---|
| Receipt number | R000028735 |
| Scientific Title | Comparison of neuromuscular monitoring between new and usual apparatus |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2018/05/23 15:21:02 |
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Basic information
Public title
Comparison of neuromuscular monitoring between new and usual apparatus
Acronym
Comparison of neuromuscular monitoring between new and usual apparatus
Scientific Title
Comparison of neuromuscular monitoring between new and usual apparatus
Scientific Title:Acronym
Comparison of neuromuscular monitoring between new and usual apparatus
Region
| Japan |
Condition
Condition
Patients of surgery in general anesthesia using neuromuscular blocking agent with supine position
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comapare new neuromuscular monitoring
funstion between new(TOF-cuff) and usual (
TOF-watch apparatus.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
TOFratio (T1/T4)
T1 twitch height
Key secondary outcomes
PTC
Supramaximal current
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of total intravenous anesthesia in supine position with both arms abducted.
Key exclusion criteria
Patients who have neuromuscular disease or take drugs which may intervent neuromuscular function.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Adachi |
Organization
Kitano Hospital The Tazuke Kofukai Medical Research Institute
Division name
Department of Anesthesiology
Zip code
Address
2-4-20 Ohgimachi, Kita-Ku, Osaka
TEL
06-6131-8824
t-adachi@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Adachi |
Organization
Kitano Hospital The Tazuke Kofukai Medical Research Institute
Division name
Department of Anesthesiology
Zip code
Address
2-4-20 Ohgimachi, Kita-Ku, Osaka
TEL
06-6131-8824
Homepage URL
t-adachi@kitano-hp.or.jp
Sponsor or person
Institute
Kitano Hospital The Tazuke Kofukai Medical Research Institute Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital The Tazuke Kofukai Medical Research Institute Department of Anesthesiology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
田附興風会医学研究所北野病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2016 | Year | 11 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028735
