UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050602 |
|---|---|
| Receipt number | R000057506 |
| Scientific Title | Pharmacokinetic model for Remimazolam in patients undergoing cardiac surgery |
| Date of disclosure of the study information | 2023/03/16 |
| Last modified on | 2024/03/15 10:27:52 |
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Basic information
Public title
Pharmacokinetic model for Remimazolam in patients undergoing cardiac surgery
Acronym
Phamcokinetic model for Remimazolam
Scientific Title
Pharmacokinetic model for Remimazolam in patients undergoing cardiac surgery
Scientific Title:Acronym
Pharmacokinetic model for Remimazolam in patients undergoing cardiac surgery
Region
| Japan |
Condition
Condition
aortic valve disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish PK model for remimazolam in patients undergoing cardiac surgery
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remimazolam is administered to patients undergoing cardiac surgery and arterial blood draws are performed as appropriate. Blood draws should be performed only during surgery.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing scheduled cardiac surgery under CPB
Key exclusion criteria
BMI >30 kg/m2, BMI <18 kg/m2, pregnant, myasthenia gravis, acute angle closure glaucoma, patients with severe hepatic dysfunction, emergency surgery
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ami |
| Middle name | |
| Last name | Sugawara |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
0788510
Address
2-1-1-1, Midorigaoka-higasi, Asahikawa
TEL
0166652111
asugawara@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Sugawara |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
0788510
Address
2-1-1-1, Midorigaoka-higasi, Asahikawa
TEL
0166652111
Homepage URL
asugawara@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa medical university Ethics Committee
Address
2-1-1-1, Midorigoka-higashi, Asahikawa
Tel
0166652111
rs-kk.g@asajolawa-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 | 03 | Month | 16 | 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
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Remimazolam is administered and blood levels are measured
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057506
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
