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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019800
Receipt No. 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

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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
Email 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
Email kunitomo19790406@yahoo.co.jp

Sponsor
Institute Anestmedical Co., Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022867

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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