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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017489
Receipt No. R000019841
Scientific Title Efficacy of muscle relaxant for tracheal intubation with AWS.
Date of disclosure of the study information 2015/05/11
Last modified on 2015/06/12

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Basic information
Public title Efficacy of muscle relaxant for tracheal intubation with AWS.
Acronym Muscle relaxant for AWS intubation
Scientific Title Efficacy of muscle relaxant for tracheal intubation with AWS.
Scientific Title:Acronym Muscle relaxant for AWS intubation
Region
Japan

Condition
Condition Patient who undergo general anesthesia with tracehalintubation
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the muscle relaxant efficacy for intubation efficacy for tracehal intubation with AWS
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intubation time, intubation success rate
laryngoscopy
insertion times of tube through glottis
glottis closeure degree
Key secondary outcomes postoperative pharyngeal pain, hoarsenee
subjective difficulty
vital sign change during intubation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Administer muscle relaxant for tracehal intubation with AWS
Interventions/Control_2 Not Administer muscle relaxant for tracehal intubation with AWS
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 need tracheal intubation during general anesthesia
Key exclusion criteria Patient for emergency operation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesthesiology
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 Muscle relaxant faciliated AWS-mediated tracheal intubation by shortening the intubation time, VAS for laryngoscopy. The laryngoscopy did not change by muscle relaxant adminstration
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 06 Month 10 Day
Date of closure to data entry
2015 Year 06 Month 10 Day
Date trial data considered complete
2015 Year 06 Month 12 Day
Date analysis concluded
2015 Year 06 Month 20 Day

Other
Other related information Hoarseness was sinigificantly smaller in MR grpup compared to C group

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2015 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019841

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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