UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031154 |
|---|---|
| Receipt number | R000035468 |
| Scientific Title | Comparative accuracy of neuromuscular monitoring between TOF-Cuff and TOF-Watch |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2019/05/22 20:56:48 |
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Basic information
Public title
Comparative accuracy of neuromuscular monitoring between TOF-Cuff and TOF-Watch
Acronym
Comparison between TOF-Cuff and TOF-Watch
Scientific Title
Comparative accuracy of neuromuscular monitoring between TOF-Cuff and TOF-Watch
Scientific Title:Acronym
Comparison between TOF-Cuff and TOF-Watch
Region
| Japan |
Condition
Condition
Surgical patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Neuromuscular monitoring is very important to know adequate dose and timing of administration of neuromuscular blocking agents and reversal agents. Until now, acceleromyograpm TOF-Watch has been used in clinical anesthesia. Recently, new type TOF-Cuff monitor is introduced clinically. The purpose of this study is to compare the acuracy of TOF-Cuff with TOF-Watch.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
onset time of rocuronium, recovery time of post-tetanic count, recovery time of TOF counts, reversal time with sugammadex
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Effect of rocuronium and sugammadex is observed using TOF-Cuff.
Interventions/Control_2
Effect of rocuronium and sugammadex is observed using TOF-Watch.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ASA classification 1-3
Patients consented to participate in this study
Key exclusion criteria
Patients havinf allergic factors to neuromuscular blocking agents and reversal agents
Patients with ASA classification 4-6
Patients with BMI>30 or <18.5
Patients with neuromuscular diseases
Patients with liver dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Kitajima |
Organization
Nihon University Itabashi Hospital
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL
0339728111
kitajima.osamu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Kitajima |
Organization
Nihon University Itabashi Hospital
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
TEL
0339728111
Homepage URL
kitajima.osamu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Nihon University Itabashi Hospital
Address
30-1 Oyaguchi Kami-cho, Itabasi-Ku, Tokyo
Tel
0339728111
kitajima.osamu@nihon-u.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
| 2018 | Year | 02 | Month | 05 | 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
20
Results
For TOF watch ,onset time was 123.5(30.5)s, recovery time of post-tetanic count was 25.4(8.6)min, recovery time of TOF counts was 38.9(11.1)min, and reversal time with sugammadex was 151.8(31.5)min.
For TOF cuff ,onset time was 127.8(27.2)s, recovery time of post-tetanic count was 23.9(8.0)min, recovery time of TOF counts was 37.2(8.8))min, and reversal time with sugammadex was 139.2(30.6)min.
Results date posted
| 2019 | Year | 05 | Month | 22 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035468
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/08/07 | TOFカフ実施計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
