UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of neuromuscular blocking agents on the management of mechaninal ventilation with supraglottic airway device and the influence of the differences between anesthetic agents or supraglottic airway devices
Title of the study (Brief title)	The effect of NMBAs on the management of mechaninal ventilation with SGA devices
Region	Japan

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

Objectives
Narrative objectives1	To clarify the proper dosage of rocuronium to decrease the leakage volume during mechanical ventilation with supraglottic airway devices. To investigate the influence of different anesthetic agents or supraglottic airway devices on this dosage.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compare the decreased leakage volume after rocuronium administration between different dose of rocuronium administrated groups
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	rocuronium dose
Interventions/Control_2	types of anesthetic drugs
Interventions/Control_3	types of supraglottic airway devices
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 scheduled for elective surgery under general anesthesia
Key exclusion criteria	morbidly obese(BMI>=35 kg/m2) gastroeshophageal reflux
Target sample size	50

Research contact person
Name of lead principal investigator	Masafumi Fujimoto
Organization	Nishinihon Hospital
Division name	department of anesthesiology
Address	3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
TEL	096-380-1111
Email	mfujimoto-kmm@umin.ac.jp

Public contact
Name of contact person	Masafumi Fujimoto
Organization	Nishinihon Hospital
Division name	department of anesthesiology
Address	3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
TEL	096-380-1111
Homepage URL
Email	mfujimoto-kmm@umin.ac.jp

Sponsor
Institute	Nishinihon Hospital
Institute
Department

Funding Source
Organization	none
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	西日本病院（熊本県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 20 Day
Anticipated trial start date	2017 Year 04 Month 20 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

Management information
Registered date	2017 Year 04 Month 19 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031018