UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011975 |
|---|---|
| Receipt number | R000013989 |
| Scientific Title | Evaluation of optimal dosage of anesthetic |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2020/03/10 14:31:46 |
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Basic information
Public title
Evaluation of optimal dosage of anesthetic
Acronym
Evaluation of optimal dosage of anesthetic
Scientific Title
Evaluation of optimal dosage of anesthetic
Scientific Title:Acronym
Evaluation of optimal dosage of anesthetic
Region
| Japan |
Condition
Condition
arteriosclerosis obliterans
ischemic heart disease
valvular disease
aneurysm of the aorta
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal dosage of propofol and remifentanil at induction of anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
remifentanil1.0ug/kg/min,propofol2ug/ml
Interventions/Control_2
remifentanil0.5ug/kg/min,propofol2ug/ml
Interventions/Control_3
remifentanil0.5ug/kg/min,propofol3ug/ml
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were scheduled to undergo peripheral vascular bypass surgery for arteriosclerosis obliterans and patients who were scheduled to undergo cardiovascular surgery(coronary artery bypass grafting, valve replacement, or replacement of the aorta)
Key exclusion criteria
arrhythmia
heart failure(EF<30%)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyama Yuki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
TEL
0166682583
toyama12@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyama Yuki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
TEL
0166682583
Homepage URL
toyama12@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 10 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013989
