UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012213 |
|---|---|
| Receipt number | R000014006 |
| Scientific Title | Suppressive effects of high-dose remifentanil on stress response of patients during cardiac surgery with cardiopulmonary bypass |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2013/11/05 03:09:56 |
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Basic information
Public title
Suppressive effects of high-dose remifentanil on stress response of patients during cardiac surgery with cardiopulmonary bypass
Acronym
Suppressive effects of high-dose remifentanil on stress response of patients during cardiac surgery with cardiopulmonary bypass
Scientific Title
Suppressive effects of high-dose remifentanil on stress response of patients during cardiac surgery with cardiopulmonary bypass
Scientific Title:Acronym
Suppressive effects of high-dose remifentanil on stress response of patients during cardiac surgery with cardiopulmonary bypass
Region
| Japan |
Condition
Condition
Patients scheduled for elective cardiac surgery with CPB
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate whether high dose remifentanil suppresses the excess stress hormones responses caused by CPB effectively compared to low dose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stress hormone response
(blood glucose, cortisol, ACTH, noradrenaline)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administer high dose remifentanil(1.0mcg/kg/min) during CPB
Interventions/Control_2
administer low dose remifentanil(0.1mcg/kg/min) during CPB
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
primary cardiac surgery using CPB
Key exclusion criteria
LVEF<25%
preoperative inotropic or intraaortic balloon pump support
emergency surgery
preoperative significant pulmonary, endocrine, metabolic, neurological disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsunehisa Tsubokawa |
Organization
Kanazawa University Hospital
Division name
Department of Anesthesiology
Zip code
Address
Takaramachi13-1, Kanazawa City, Ishikawa, Japan
TEL
0762652000
yfujii@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Fujii |
Organization
Kanazawa University Hospital
Division name
Department of Anesthesiology
Zip code
Address
Takaramachi13-1, Kanazawa, Ishikawa
TEL
0762652000
Homepage URL
yfujii@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kanazawa University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | 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
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
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2010 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 05 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014006
