UMIN-CTR Clinical Trial

Basic information
Public title	Appropriate muscular relaxation level during positive pressure ventilation using supraglottic airway devices
Acronym	Supraglottic airway device and muscle relaxation
Scientific Title	Appropriate muscular relaxation level during positive pressure ventilation using supraglottic airway devices
Scientific Title:Acronym	Supraglottic airway device and muscle relaxation
Region	Japan

Condition
Condition	patients under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Insertion of supraglottic device was able to be performed without muscular relaxant. Laryngospasm sometimes occurs during and after an insertion of supraglotitc device when muscular relaxant is not used. Although the use of muscular relaxant may make an insertion of supraglotic device safe, we do not know an appropriate muscle relaxation level during an insertion of supraglottic device. In the present study, we will evaluate an appropriate level of muscle relaxation during an insertion of supraglottic device.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between muscular relaxation level and leak pressure of supraglottic device.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	dose of rocuronium
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients under general anesthesia
Key exclusion criteria	ineligible patients
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuo Yamamoto
Organization	Kumamoto University Hospital
Division name	Anesthesiology
Zip code
Address	1-1-1 Honjyo, chuo-ku, Kumamoto-shi
TEL	0963735275
Email	yamyam@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tatsuo Yamamoto
Organization	Kumamoto University Hospital
Division name	Anesthesiology
Zip code
Address	1-1-1 Honjyo, chuo-ku, Kumamoto-shi
TEL	096-373-5275
Homepage URL	http://kuma-ma.com/
Email	yamyam@kumamoto-u.ac.jp

Sponsor
Institute	Department of Anesthesiology Kumamoto University Hospital
Institute
Department

Funding Source
Organization	Kumamoto University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 13 Day
Date of IRB	2017 Year 11 Month 21 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2018 Year 05 Month 30 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2019 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034222