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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009941
Receipt No. R000011644
Scientific Title Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Date of disclosure of the study information 2013/04/01
Last modified on 2020/04/01

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Basic information
Public title Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Acronym Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Scientific Title Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Scientific Title:Acronym Investigation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Region
Japan

Condition
Condition Patients scheduled for general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effects of changing volatile anesthetics after induction on the recovery from general anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to open eyes to the verbal command after general anesthesia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction and maintenance with sevoflurane
Interventions/Control_2 Induction with sevoflurane and maintenance with desflurane
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients, scheduled for general anesthesia, age equal to or more than 20, ASA physical status I-III
Key exclusion criteria Patient refusal, contraindication for the drugs used in the protocol
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ikuomi
Middle name
Last name Mikuni
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 078-8510
Address 2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL 0166-68-2583
Email mikuni-ikuomi@kbd.biglobe.ne.jp

Public contact
Name of contact person
1st name Ikuomi
Middle name
Last name Mikuni
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 078-8510
Address 2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL 0166-68-2583
Homepage URL
Email mikuni-ikuomi@kbd.biglobe.ne.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Asahikawa Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asahikawa Medical University
Address 2-1-1-1 Midorogaoka Higashi, Asahikawa, Hokkaido, JAPAN
Tel 0166-68-2583
Email mikuni-ikuomi@kbd.biglobe.ne.jp

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 旭川医科大学病院(北海道)
釧路赤十字病院(北海道)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000011644
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s12630-015-0514-9
Number of participants that the trial has enrolled 52
Results
Emergence and recovery were significantly faster in the desflurane group than the sevoflurane group.
Results date posted
2020 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were
patients aged over 20 years and American Society of
Anesthesiologists physical status I-III.
Participant flow
Patients were randomly assigned to either the sevoflurane group or the desflurane group.
Adverse events
None.
Outcome measures
The time from discontinuation of volatile anesthetics to eye opening, obeying the command to squeeze the investigator's hand, tracheal extubation, and orientation to the patients' full name, date and place. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 03 Day
Date of IRB
2013 Year 02 Month 27 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2015 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 03 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011644

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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