UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016053 |
|---|---|
| Receipt number | R000018616 |
| Scientific Title | The effects of remifentanil anesthesia on glucose control in diabetic patients undergoing coronary artery bypass graft surgery |
| Date of disclosure of the study information | 2014/12/25 |
| Last modified on | 2014/12/25 12:27:06 |
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Basic information
Public title
The effects of remifentanil anesthesia on glucose control in diabetic patients undergoing coronary artery bypass graft surgery
Acronym
Remifentanil anesthesia on glucose control in diabetic patients
Scientific Title
The effects of remifentanil anesthesia on glucose control in diabetic patients undergoing coronary artery bypass graft surgery
Scientific Title:Acronym
Remifentanil anesthesia on glucose control in diabetic patients
Region
| Japan |
Condition
Condition
Diabetic patients undergoing coronary artery bypass graft surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of remifentanil and fentanyl anesthesia on glucose control in diabetic patients undergoing coronary artery bypass graft surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the levels of glucose in the blood
the levels of adrenaline in the blood
the levels of noradrenaline in the blood
the levels of cortisol in the blood
the levels of insuline in the blood
Key secondary outcomes
Base
Study type
Interventional
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
fentanyl-propofol based anesthesia for coronary artery bypass graft surgery
Interventions/Control_2
remifentanil-propofol based anesthesia for coronary artery bypass graft surgery
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
Diabetic patients undergoing off-pump coronary artery bypass graft surgery
Key exclusion criteria
Emergency surgeries
hemodialysis patients
The patient whom insulin, adrenalin, and steroid was used for in anesthesia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Kitagawa |
Organization
Shiga university of medical science
Division name
Department of anesthesiology
Zip code
Address
Setatsukinowa-cho, Otsu-shi, Shiga
TEL
077-548-2281
hirotosi@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Kitagawa |
Organization
Shiga university of medical science
Division name
Department of anesthesiology
Zip code
Address
Setatsukinowa-cho, Otsu-shi, Shiga
TEL
077-548-2281
Homepage URL
hirotosi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of medical science
Institute
Department
Personal name
Funding Source
Organization
Shiga university of medical science
Organization
Division
Category of Funding 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
| 2014 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 05 | 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
| 2014 | Year | 12 | Month | 25 | Day |
Last modified on
| 2014 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018616
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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