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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024968
Receipt No. R000028727
Scientific Title Utility of new muscular flaccidity monitorTOFCuff
Date of disclosure of the study information 2016/11/24
Last modified on 2018/07/02

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Basic information
Public title Utility of new muscular flaccidity monitorTOFCuff
Acronym Utility of TOFCuff
Scientific Title Utility of new muscular flaccidity monitorTOFCuff
Scientific Title:Acronym Utility of TOFCuff
Region
Japan

Condition
Condition The operation patient who needs general anesthesia 15 years or older
Classification by specialty
Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Utility of TOFCuff at the time of the general anesthesia operation, monitoring anesthesia maintenance, degree of the line relaxation at the time of the extubation at the time of anesthesia introduction and weigh it against an evaluation in conventional TOF-Watch.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of the line relaxation monitoring in TOF-Watch and TOFCuff
Key secondary outcomes Having or not early post operation respiratory dysfunction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 measuring TOF count before administration of rocuronium
Interventions/Control_2 After administration rocuronium, measuring TOF count or TOF ratio in parallel in TOFCUff and TOF-Watch every 30 seconds
Interventions/Control_3 After the operation, measuring similarly administration of sugammadex
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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The patient who it is a state of ASA-PS 1-2, and does not correspond to exclusion criteria
Key exclusion criteria Patient younger than 15 years
Patient having a neuromuscular disease
Patient having a renal function disorder
Patient having a liver function disorder
Patient thought to be the skin state having difficulty in line relaxation monitoring
The patient whom a study representative or an allotment researcher judged not to be able to evaluate it who it is not cooperative or is enough after a study start during a period until leaving
In addition, the patient who judged that a study representative or an allotment researcher was inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Yamakage
Organization Sapporo medical university hospital
Division name Department of Anesthesiology
Zip code
Address South 1, West 16 chuo-ku, Sapporo
TEL 011-611-2111
Email yamakage@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kazuma
Organization Sapporo medical university hospital
Division name Department of Anesthesiology
Zip code
Address South 1, West 16 chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email sea_hawk_3104@yahoo.co.jp

Sponsor
Institute Sapporo medical university hospital, Department of Anesthesiology
Institute
Department

Funding Source
Organization Sapporo medical university hospital, Department of Anesthesiology
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
Email

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 11 Month 24 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 Completed
Date of protocol fixation
2016 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 25 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 24 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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