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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014897
Receipt No. R000017286
Scientific Title Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients : A prospective randomized controlled trial
Date of disclosure of the study information 2014/09/01
Last modified on 2014/10/31

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Basic information
Public title Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients : A prospective randomized controlled trial
Acronym Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients
Scientific Title Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients : A prospective randomized controlled trial
Scientific Title:Acronym Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients
Region
Japan

Condition
Condition Patients who undergo general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ventilation success, sealing pressure
Key secondary outcomes Pharyngealpain, hoarseness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rocronium administration
Interventions/Control_2 No rocronium administration
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
85 years-old >
Gender Male
Key inclusion criteria Patients who underwentgeneral anesthesia
Key exclusion criteria Patients who are contraindicated for SGD use.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Nishihara
Organization Hokusetsu General Hospital
Division name Anesthesiology
Zip code
Address 6-24, Kitayanagawa, Takatsuki, Osaka
TEL 072-696-2121
Email xn6i-nshr@asahi-net.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyasu Komasawa
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7Daigaku-machi, Takatsuki city
TEL 072-696-2121
Homepage URL
Email koma21century@yahoo.co.jp

Sponsor
Institute Hokusetsu General Hospital
Institute
Department

Funding Source
Organization Osaka MedicalCollege
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
2014 Year 09 Month 01 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
Sealing pressure and insertion success rate was significantly higher in muscle relaxant groups.
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
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 02 Day
Last follow-up date
2014 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 19 Day
Last modified on
2014 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017286

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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