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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009164
Receipt No. R000010748
Scientific Title Investigation into changes of the glottic larynx during general anesthesia
Date of disclosure of the study information 2012/10/22
Last modified on 2015/05/07

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Basic information
Public title Investigation into changes of the glottic larynx during general anesthesia
Acronym Investigation into changes of the glottic larynx during general anesthesia
Scientific Title Investigation into changes of the glottic larynx during general anesthesia
Scientific Title:Acronym Investigation into changes of the glottic larynx during general anesthesia
Region
Japan

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

Objectives
Narrative objectives1 Comparison about changes of the glottic larynx between inhalation anesthetic drugs and intravenous anesthetic drugs
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of changes of glottic opening area and airway pressure during general anesthesia between groups
Key secondary outcomes Comparison of incidence of airway trouble and medical intervention during general anesthesia between groups

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Elective surgical patients using supraglottic airway device under general anesthesia after February 2012 are randomly assigned to three groups by anesthetic drug used for maintainance of anesthesia. Group1includes patients using desflurane.
Interventions/Control_2 Group2includes patients using sevoflurane.
Interventions/Control_3 Group3includes patients using propofol.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria elective surgical patients using supraglottic airway device under general anesthesia
Key exclusion criteria history of severe broncheal asthma, obstructive pulmonary disease, or malignant hyperthermia
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kondo
Organization Akane Foundation Tsuchiya General Hospital
Division name Department of Anesthesia
Zip code
Address 3-30 Nakajimacho, Naka-ku Hiroshima, Japan
TEL 082-243-9191
Email yrdcn850@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kondo
Organization Akane Foundation Tsuchiya General Hospital
Division name Department of Anesthesia
Zip code
Address 3-30 Nakajimacho, Naka-ku Hiroshima, Japan
TEL 082-243-9191
Homepage URL
Email yrdcn850@yahoo.co.jp

Sponsor
Institute Akane Foundation Tsuchiya General Hospital
Institute
Department

Funding Source
Organization None
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
2012 Year 10 Month 22 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
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 21 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
2015 Year 02 Month 28 Day
Date trial data considered complete
2015 Year 02 Month 28 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 22 Day
Last modified on
2015 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010748

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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