UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body
Title of the study (Brief title)	Reversal of Neuromuscular Blockade with Sugammadex Based on the Residual of Rocuronium in the Body
Region	Japan

Condition
Condition	Patients scheduled for elective surgery requiring general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the reversal of the neuromuscular blockade with sugammadex which dose was calculated from the residual of rocuronium using pharmacokinetic simulation
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of neuromuscular responses with a peripheral neurostimulator
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	the group in which sugammadex are administered 2mg/kg
Interventions/Control_2	the group in which sugammadex are administered 4 times the residual amount of rocuronium
Interventions/Control_3	the group in which sugammadex are administered 6 times the residual amount of rocuronium
Interventions/Control_4	the group in which sugammadex are administered 8 times the residual amount of rocuronium
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	the patients scheduled for elective surgery requiring general anesthesia the patients were ASA physical status 1-2
Key exclusion criteria	the patients were ASA physical status 3-4 the patients who have cardiac, hepatic, renal or neuromuscular disorders the patients who are scheduled hepatic or renal surgery
Target sample size	120

Research contact person
Name of lead principal investigator	Satoshi Shibuta
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology and Intensive Care
Address	2-2, Yamadaoka, Suita-shi, Osaka, Japan
TEL	+81-6-6879-3133
Email	shibuta@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	Tomotaka Morita
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology and Intensive Care
Address	2-2, Yamadaoka, Suita-shi, Osaka, Japan
TEL	+81-6-6879-3133
Homepage URL
Email	tmorita@anes.med.osaka-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Intensive Care, Osaka University Graduate School of Medicine
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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 26 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 03 Month 06 Day

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

Management information
Registered date	2015 Year 04 Month 13 Day
Last modified on	2018 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016002