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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017488
Receipt No. R000019840
Scientific Title Efficacy of muscle relaxant for supraglottic device insertion
Date of disclosure of the study information 2015/05/11
Last modified on 2015/07/04

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Basic information
Public title Efficacy of muscle relaxant for supraglottic device insertion
Acronym Significance of muscle relaxant for supraglottic device insertion
Scientific Title Efficacy of muscle relaxant for supraglottic device insertion
Scientific Title:Acronym Significance of muscle relaxant for supraglottic device insertion
Region
Japan

Condition
Condition Patient who undergo general anesthesia with supraglottic device
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effect of muscle relaxant for insertion efficacy of SGD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Insertion Success rate
Sealing Pressure
Key secondary outcomes Postoperative pharyngeal pain, hoarseness
Subjective difficulty of insertion

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To administer muscle relaxant on supraglottic device insertion
Interventions/Control_2 Not to administer muscle relaxant on supraglottic device insertion
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 Patient who undergo general anesthesia with SGD
Key exclusion criteria Patient who are contraindicated for SGD insertion.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesgthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 0726-84-6361
Email ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Komasawa Nobuyasu
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7Daigaku-machi, Takatsuki city
TEL 0726-84-6361
Homepage URL
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 11 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 Insertion succesfful rate, sealing pressure were improved by muscle relaxant performed by novice doctors.
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
2015 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 11 Day
Last follow-up date
2015 Year 07 Month 04 Day
Date of closure to data entry
2015 Year 07 Month 10 Day
Date trial data considered complete
2015 Year 07 Month 14 Day
Date analysis concluded
2015 Year 07 Month 15 Day

Other
Other related information Subjective diffficulty of insertion was also improved.

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2015 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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