UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of rocuronium-induced muscle relaxant on oxygen metabolism of skeletal muscle tissue.
Title of the study (Brief title)	Effect of muscle relaxant agent on oxygen metabolism of skeletal muscle tissue.
Region	Japan

Condition
Condition	Patients undergoing elective surgery under general anesthesia.
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Rocurunium-induced muscle relaxtant whether or not reduces oxygen metabolism of skeletal muscle tissue, evaluated by near infrared spectroscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in oxygen metabolism of skeletal muscle tissue during recovery process from rocuronium-induced muscle relaxtant induced by sugammadex.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients aged 20 years and older, ASA grade 1 or 2, who are scheduled elective surgery under general anesthesia.
Key exclusion criteria	neuromuscular disease patients patients clssified as ASA grade 3
Target sample size	30

Research contact person
Name of lead principal investigator	Noriya Hirose
Organization	Nihon University School of Medicine
Division name	Division of Anesthesiology, Deparetment of Anesthesiology
Address	30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	hirose.noriya@nihon-u.ac.jp

Public contact
Name of contact person	Noriya Hirose
Organization	Nihon University School of Medicine
Division name	Division of Anesthesiology, Deparetment of Anesthesiology
Address	30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	hirose.noriya@nihon-u.ac.jp

Sponsor
Institute	Nihon University Itabashi Hospital, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Nihon University School of Medicine
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	日本大学医学部附属板橋病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 08 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	Study design: Observational study Participants: Patients who will be received elective surgery under general anesthesia during June 2016 to August 2016. Observation items: Change in oxygen metabolism of skeletal muscle tissue during recovery process from rocuronium-induced muscle relaxtant induced by sugammadex, evaluated by near infrared spectroscopy (NIRS).

Management information
Registered date	2016 Year 06 Month 08 Day
Last modified on	2016 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026109