UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025248 |
|---|---|
| Receipt number | R000029042 |
| Scientific Title | Compare the muscle relaxation recovery process between TOFwatch and TOFcuff after sugammadex administered |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2020/03/12 13:52:04 |
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Basic information
Public title
Compare the muscle relaxation recovery process between TOFwatch and TOFcuff after sugammadex administered
Acronym
Comparison of TOFwatch and TOFcuff
Scientific Title
Compare the muscle relaxation recovery process between TOFwatch and TOFcuff after sugammadex administered
Scientific Title:Acronym
Comparison of TOFwatch and TOFcuff
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia for surgery in which both upper limbs do not become surgical fields
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the utility of TOF cuff by using at the same time during surgery both TOF watch and TOF cuff.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time until the TOF ratio reached 90% aftersugammadex was administered.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Supine position
2)Both upper limbs are not surgical field
3)The patients were ASA physical status 1-2
Key exclusion criteria
1)Patient with neuromuscular disease
2)Patient with liver and renal dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Iwasaki |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL
0166-65-2111
iwasakih@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Oshiro |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL
0166-65-2111
Homepage URL
masaya.o1986@gmail.com
Sponsor or person
Institute
Asahikawa Medical University,Anesthesiology and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University,Anesthesiology and Critical Care Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sugamadex is administered after surgery and the TOF ratio is measured. further, the time from the administration to the time when the TOF ratio reaches 90% is measured.
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029042
