UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of age on recovery from neuromuscular blockade with and without sugammadex
Title of the study (Brief title)	Recovery from neuromuscular block with sugammadex and aging
Region	Japan

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

Objectives
Narrative objectives1	To test an hypothesis that aging effects recovery from non-depolizing neuromuscular block with sugammadex.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Train of four ratio
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	aging
Interventions/Control_2	sugammadex administration
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	Adult patients scheduled for surgeries undergoing general anesthesia
Key exclusion criteria	Patients with ASA class greater than 3, allergies for rocuronium and/or propofol and sugammadex, and patients who is contraindicated for administration of neuromuscular blockade and sugammadex.
Target sample size	40

Research contact person
Name of lead principal investigator	Shiroh Isono
Organization	Graduate School of Medhicine, Chiba University
Division name	Department of Anesthesiology
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2155
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Graduate School of Medhicine, Chiba University
Division name	Department of Anesthesiology
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2155
Homepage URL
Email	shirohisono@yahoo.co.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University, Department of Anesthesiology
Institute
Department

Funding Source
Organization	Institutional
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	2013 Year 12 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 12 Day
Anticipated trial start date	2013 Year 12 Month 24 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded

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

Management information
Registered date	2013 Year 12 Month 23 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014804