UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of neuromuscular monitoring between new and usual apparatus
Title of the study (Brief title)	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	Takehiko Adachi
Organization	Kitano Hospital The Tazuke Kofukai Medical Research Institute
Division name	Department of Anesthesiology
Address	2-4-20 Ohgimachi, Kita-Ku, Osaka
TEL	06-6131-8824
Email	t-adachi@kitano-hp.or.jp

Public contact
Name of contact person	Takehiko Adachi
Organization	Kitano Hospital The Tazuke Kofukai Medical Research Institute
Division name	Department of Anesthesiology
Address	2-4-20 Ohgimachi, Kita-Ku, Osaka
TEL	06-6131-8824
Homepage URL
Email	t-adachi@kitano-hp.or.jp

Sponsor
Institute	Kitano Hospital The Tazuke Kofukai Medical Research Institute Department of Anesthesiology
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028735