UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051469 |
|---|---|
| Receipt number | R000058714 |
| Scientific Title | Changes in plasma protein binding rate of remifentanil during cardiopulmonary bypass |
| Date of disclosure of the study information | 2023/06/28 |
| Last modified on | 2023/06/28 15:19:53 |
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Basic information
Public title
Changes in plasma protein binding rate of remifentanil during cardiopulmonary bypass
Acronym
Changes in plasma protein binding rate of remifentanil during cardiopulmonary bypass
Scientific Title
Changes in plasma protein binding rate of remifentanil during cardiopulmonary bypass
Scientific Title:Acronym
Changes in plasma protein binding rate of remifentanil during cardiopulmonary bypass
Region
| Japan |
Condition
Condition
protein binding rate of remifentanil
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of changes in the protein binding rate of remifentanil during cardiopulmonary bypass
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
protein binding rate of remifentanil
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Undergoing heart or great vessel surgery using a heart-lung machine
Use intraoperative remifentanil
Gender does not matter
18 years of age or older
ASA-PS (American Society of Anesthesiologists physical status) 1-3
Those who have been able to obtain consent for this research by signing a consent form by the person himself/herself or a proxy
Key exclusion criteria
Allergy to remifentanil
Preoperative blood hemoglobin concentration of 7 g/dl or less
Persons who could not obtain consent by signing a consent form by themselves or their legal representatives
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueda |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
TEL
0534352738
07484827@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueda |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care
Zip code
4313192
Address
1-20-1 handayama, higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
0534352738
Homepage URL
07484827@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
Tel
0534352680
rinri@hama-med.ac.jp
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
| 2023 | Year | 06 | Month | 28 | 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
13
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
| 2017 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058714
