UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of new muscular flaccidity monitorTOFCuff
Title of the study (Brief title)	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	Michiaki Yamakage
Organization	Sapporo medical university hospital
Division name	Department of Anesthesiology
Address	South 1, West 16 chuo-ku, Sapporo
TEL	011-611-2111
Email	yamakage@sapmed.ac.jp

Public contact
Name of contact person	Satoshi Kazuma
Organization	Sapporo medical university hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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