UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019800 |
|---|---|
| Receipt number | R000022867 |
| Scientific Title | Desflurane compared with sevoflurane on quality of recovery and satisfaction in ambulatory anesthesia using laryngeal mask: randomized double-blinded controlled trial |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2015/11/16 15:19:23 |
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Basic information
Public title
Desflurane compared with sevoflurane on quality of recovery and satisfaction in ambulatory anesthesia using laryngeal mask: randomized double-blinded controlled trial
Acronym
Desflurane compared with sevoflurane on quality of recovery and satisfaction
Scientific Title
Desflurane compared with sevoflurane on quality of recovery and satisfaction in ambulatory anesthesia using laryngeal mask: randomized double-blinded controlled trial
Scientific Title:Acronym
Desflurane compared with sevoflurane on quality of recovery and satisfaction
Region
| Japan |
Condition
Condition
Healty Rhinitis or sinusitis patients
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We verify that whether there is validity to the early outcomes than sevoflurane by Desflurane use
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Time until to eat
We will be evaluated until hospital discharge
Key secondary outcomes
time until to walk, time until to drink, patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Until discharge from hospitalization (about 8 hours)
Desflurane4~5%
Interventions/Control_2
Until discharge from hospitalization (about 8 hours)
Sevofluran1%
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
age:18~60y.o.
male, female
ASAPS1~2
Key exclusion criteria
ASAPS3~5
Target sample size
161
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunitomo Kashiwagi |
Organization
ANESTMEDICAL Co., Ltd.
Division name
CEO
Zip code
Address
Hinode7-4-18, Urayasu, Chiba City
TEL
0473803954
kunitomo19790406@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunitomo Kashiwagi |
Organization
Anestmedical Co., Ltd.
Division name
Ansthesiology
Zip code
Address
Hinode7-4-18, Urayasu, Chiba City
TEL
0473803954
Homepage URL
kunitomo19790406@yahoo.co.jp
Sponsor or person
Institute
Anestmedical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Anestmedical Co., Ltd.
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
鼻のクリニック東京
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
Desflurane retains faster eating than does sevoflurane significantly.
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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 20 | Day |
Other
Other related information
There was no significant in other factors.
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2015 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022867
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
