UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009164 |
|---|---|
| Receipt number | 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 13:18:37 |
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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
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
yrdcn850@yahoo.co.jp
Sponsor or person
Institute
Akane Foundation Tsuchiya General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010748
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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