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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016836
Receipt No. R000019540
Scientific Title The Effect of Inhalation Anethetics on Off-pump Coronary Artery Bypass Grafting -Hemodynamic Change-
Date of disclosure of the study information 2015/04/01
Last modified on 2015/03/18

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Basic information
Public title The Effect of Inhalation Anethetics on Off-pump Coronary Artery Bypass Grafting
-Hemodynamic Change-
Acronym The Effect on Inhalation Anethetics in OPCABG
Scientific Title The Effect of Inhalation Anethetics on Off-pump Coronary Artery Bypass Grafting
-Hemodynamic Change-
Scientific Title:Acronym The Effect on Inhalation Anethetics in OPCABG
Region
Japan

Condition
Condition angina
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study of effect on inalation anethetic in OPCABG
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes amount of vasopressor drug,parameter of hemodynamic changes
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants 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 sevoflurane
Interventions/Control_2 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 to OPCABG
Key exclusion criteria patients converted to Cardiopulmonary bypass,
patients with intraaortic baloon pumping
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Ichikawa
Organization Saitama medical university International medical center
Division name department of Anethesiology
Zip code
Address 1397-1 yamane,Hidaka-city, Saitama
TEL 042-984-4111
Email yukiichikawa8@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Ichikawa
Organization Saintama medical university international medical center
Division name department of anethesiology
Zip code
Address 1397-1 yamane,Hidaka-city,saitama
TEL 042-984-4111
Homepage URL
Email yukiichikwa8@gmail.com

Sponsor
Institute Saitama medical university international medical center
Institute
Department

Funding Source
Organization Saitama medical university international medical center
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 18 Day
Last modified on
2015 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019540

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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