UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neuromuscular block required for prevention of foot movement during transurethral resection of the bladder tumor under general anesthesia
Title of the study (Brief title)	Sufficient neuromuscular block for TUR-Bt
Region	Japan

Condition
Condition	Patients undergoing elective transurethral resection of the bladder tumor under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the dosage of neuromuscular blocking agents and the degree of neuromuscular block recuired for prevention of foot movement during transurethral resection of the bladder tumor under general anesthesia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The neuromuscular blocking agent is administrated dividedly. When the foot movement caused by stimulation of obturator nerve is disappeared, the cumulative dose of that is recorded.
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	20 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Elective transurethral resection of the bladder tumor under general anesthesia,
Key exclusion criteria	severe coagulopathy
Target sample size	20

Research contact person
Name of lead principal investigator	Tatsuo Yamamoto
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Anesthesiology
Address	Kumamoto University Hospital, 1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan, 860-8556
TEL	096-373-5275
Email	yamyam@kumamoto-u.ac.jp

Public contact
Name of contact person	Masafumi Fujimoto
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Anesthesiology
Address	Kumamoto University Hospital, 1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan, 860-8556
TEL	096-373-5275
Homepage URL
Email	mfujimoto-kmm@umin.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto University
Organization
Division
Category of Funding Organization	Self funding
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 07 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 07 Month 27 Day
Last follow-up date	2017 Year 11 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/aas.13045/full
Results
Other related information	The neuromuscular blocking agent is administrated dividedly. When the foot movement caused by stimulation of obturator nerve is disappeared, the cumulative dose of that is recorded.

Management information
Registered date	2016 Year 07 Month 27 Day
Last modified on	2018 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026907