UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016836 |
|---|---|
| Receipt number | 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 18:20:42 |
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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
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
yukiichikwa8@gmail.com
Sponsor or person
Institute
Saitama medical university international medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019540
