UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057220 |
|---|---|
| Receipt number | R000065213 |
| Scientific Title | A prospective observational study on the usefulness of effect site concentrations of remimazolam during general anesthesia |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2026/05/07 14:36:16 |
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Basic information
Public title
A prospective observational study on the usefulness of effect site concentrations of remimazolam during general anesthesia
Acronym
usefulness of effect site concentrations of remimazolam
Scientific Title
A prospective observational study on the usefulness of effect site concentrations of remimazolam during general anesthesia
Scientific Title:Acronym
usefulness of effect site concentrations of remimazolam
Region
| Japan |
Condition
Condition
Adult patients scheduled to undergo general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether the effect of remimazolam on the concentration of the drug at the site of action when the patient's response to the induction of anesthesia disappears can be used as an indicator for administration during general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect site concentration of remimazolam when patient loses response and regains consciousnes
Key secondary outcomes
Relationship between EEG (BIS value) and effect site concentration of remimazolam
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have given their written consent of their own free will after being fully explained about the research.
Key exclusion criteria
1) Patients with ASA (American Society of Anesthesiologists) classification III or higher
2) Patients aged 80 years or older
3) Patients with a history of neurological disease
4) Patients who regularly take benzodiazepine sleeping pills before surgery
5) Patients who the principal investigator or sub-investigator deems unsuitable for this clinical trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Morimoto |
Organization
Ube Central Hospital
Division name
Department of Anesthesiology
Zip code
755-0151
Address
750 Nishikiwa Ube Yamaguchi
TEL
0836519221
yasumorimo@gmail.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Oka |
Organization
Ube Central Hospital
Division name
Department of Pharmacy
Zip code
755-0151
Address
750 Nishikiwa Ube Yamaguchi
TEL
0836519221
Homepage URL
Tomoyuki.oka@ube-hp.or.jp
Sponsor or person
Institute
Ube Central Hospital
Institute
Department
Personal name
Yasuhiro Morimoto
Funding Source
Organization
Ube Central Hospital
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
Ube Central Hospital
Address
750 Nishikiwa Ube
Tel
0836519221
tomoyuki.oka@ube-hp.or.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
| 2025 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-026-03734-8
Number of participants that the trial has enrolled
50
Results
Effect-site concentration simulation is useful for estimating adequate anesthetic depth and predicting emergence during remimazolam anesthesia. EEG-derived indices, particularly BIS, have limited reliability. Further studies using TCI systems and higher concentration ranges are needed to refine dosing strategies and fully characterize EEG-drug interactions.
Results date posted
| 2026 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | 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
Observation items
Gender, age, height, weight, American Society of Anesthesiologists anesthesia risk classification
Patient response When the patient loses consciousness and regains consciousness, the effect site concentration of remimazolam and the effect site concentration of remifentanil
Blood pressure, heart rate, body temperature, electroencephalogram (BIS value), and the effect site concentration of remimazolam from the time of induction of anesthesia to the time of the end of anesthesia (extracting the record every minute from the automatic anesthesia recorder)
Management information
Registered date
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065213
