UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060265 |
|---|---|
| Receipt number | R000068011 |
| Scientific Title | Elucidation of Changes in Plasma Concentration and Protein Binding Ratio of Propofol during Co-administration with Remimazolam |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2026/01/06 00:17:11 |
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Basic information
Public title
Elucidation of Changes in Plasma Concentration and Protein Binding Ratio of Propofol during Co-administration with Remimazolam
Acronym
Elucidation of Changes in Plasma Concentration and Protein Binding Ratio of Propofol during Co-administration with Remimazolam
Scientific Title
Elucidation of Changes in Plasma Concentration and Protein Binding Ratio of Propofol during Co-administration with Remimazolam
Scientific Title:Acronym
Elucidation of Changes in Plasma Concentration and Protein Binding Ratio of Propofol during Co-administration with Remimazolam
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate whether co-administration of remimazolam during propofol-induced general anesthesia affects the plasma concentration and protein binding of propofol, and to determine the extent of these changes.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Propofol plasma concentration and protein binding ratio
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
Co-administration of remimazola
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective non-cardiac surgery under general anesthesia
Key exclusion criteria
Patients with an allergy to propofol
Patients with an allergy to remimazolam
Patients who are on regular or as-needed benzodiazepine therapy
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-shi, Shizuoka 431-3192, 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-shi, Shizuoka 431-3192, 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-financed
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-shi, Shizuoka 431-3192, 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
| 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
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2028 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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/icdr_e/ctr_view.cgi?recptno=R000068011
