UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058076 |
|---|---|
| Receipt number | R000066374 |
| Scientific Title | Examination of the relationship between blood concentrations of remimazolam and BIS and PSI values |
| Date of disclosure of the study information | 2025/06/04 |
| Last modified on | 2025/06/04 09:15:06 |
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Basic information
Public title
Examination of the relationship between blood concentrations of remimazolam and BIS and PSI values
Acronym
Examination of the relationship between blood concentrations of remimazolam and BIS and PSI values
Scientific Title
Examination of the relationship between blood concentrations of remimazolam and BIS and PSI values
Scientific Title:Acronym
Examination of the relationship between blood concentrations of remimazolam and BIS and PSI values
Region
| Japan |
Condition
Condition
Patients who underwent surgery under remimazolam anesthesia at Kyushu University Hospital
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Remimazolam has been reported to have higher BIS and PSI values than propofol during optimal sedation. However, these reports define optimal sedation based on hemodynamic parameters such as blood pressure, without considering plasma concentrations. Using a plasma concentration simulator tailored to the characteristics of remimazolam, we will compare plasma concentrations with BIS and PSI values.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between blood concentration at bedtime and time until awakening
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
(1) Patients who underwent surgery at Kyushu University Hospital under remimazolam anesthesia
(2) Patients aged 18 years or older at the time of surgery
(3) Patients who had a BIS monitor and SedLine monitor attached at the time of surgery
(4) ASA status 3 or lower.
Key exclusion criteria
(1) Individuals who underwent surgery using methods other than general anesthesia (local anesthesia).
(2) Surgery performed in the prone position.
(3) Surgery using artificial heart-lung support.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kazuhiro |
| Middle name | |
| Last name | shirozu |
Organization
kyushu university hospital
Division name
operating rooms
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku fukuoka
TEL
092-642-5714
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | kazuhiro |
| Middle name | |
| Last name | shirozu |
Organization
kyushu university hospital
Division name
operating rooms
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku fukuoka
TEL
092-642-5714
Homepage URL
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Center for Clinical and Translational Research.
Address
3-1-1 Maidashi Higashi-ku fukuoka
Tel
092-642-5858
tr-info@med.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23260-01
Org. issuing International ID_1
23260-01
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 04 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066374
