UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060266 |
|---|---|
| Receipt number | R000058881 |
| Scientific Title | Clarification of changes in plasma concentration and protein binding rate of remimazolam when co-administered with propofol. |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2026/01/06 00:29:31 |
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Basic information
Public title
Changes in blood concentration and protein binding of the benzodiazepine sedative remimazolam during co-administration with the general anesthetic propofol.
Acronym
Clarification of changes in plasma concentration and protein binding rate of remimazolam when co-administered with propofol.
Scientific Title
Clarification of changes in plasma concentration and protein binding rate of remimazolam when co-administered with propofol.
Scientific Title:Acronym
Clarification of changes in plasma concentration and protein binding rate of remimazolam when co-administered with propofol.
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the actual changes in plasma concentration and protein binding of remimazolam during concomitant administration with propofol.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration and protein binding rate of remimazolam
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After the induction of general anesthesia with remimazolam is completed, continuous infusion of propofol is initiated.
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
Patients undergoing elective surgery under general anesthesia
ASA classification 1 to 3
No allergy to remimazolam or propofol
Obtain written consent from the person or legally acceptable person
Key exclusion criteria
ASA classification 4 or higher
Allergic to remimazolam and propofol
Written consent cannot be obtained from the person himself/herself or a legal representative
Target sample size
15
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 Medical Education, Faculty of Medicine
Zip code
4313192
Address
1-20-1, handayama, Chuo-ku, hamamatsu, shizuoka, JAPAN
TEL
0534352738
hueda-ham@umin.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 Medical Education, Faculty of Medicine
Zip code
4313192
Address
1-20-1 handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
0534352738
Homepage URL
hueda-ham@umin.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, handayama, Chuo-ku, hamamatsu, shizuoka, JAPAN
Tel
0534352738
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
| 2026 | Year | 01 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058881
