UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between patient's factors and the effect of rocuronium and sugammadex
Title of the study (Brief title)	Correlation between patient's factors and the effect of rocuronium and sugammadex
Region	Japan

Condition
Condition	Patients undergoing surgery under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to inestigate the correlation between patient's factors and the effect of rocuronium and sugammadex.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Monitoring of neuromuscular function by train of four stimulation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients undergoing surgery under general anesthesia
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	Masafumi Fujimoto
Organization	Graduate school of Medical Science, Kumamoto University
Division name	Department of Anesthesiology
Address	1-1-1, Honjyo, Kumamoto-City, Kumamoto, Japan
TEL	096-373-5275
Email	mfujimoto-kmm@umin.ac.jp

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

Sponsor
Institute	Department of Anesthesiology, Graduate school of Medical Science, Kumamoto University
Institute
Department

Funding Source
Organization	none
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	熊本大学医学部附属病院（熊本県）

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The correlation between patient's backgrounds (age, sex, height, weight, body mass index, laboratory data and previous illness) and the effect of rocuronium (onset time and duration time) or recovery time of rocuronium-induced neuromuscular block after reversal with sugammadex are investigated prospectively.

Management information
Registered date	2011 Year 11 Month 24 Day
Last modified on	2017 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008006