UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061885 |
|---|---|
| Receipt number | R000069019 |
| Scientific Title | A Study on the Amnesic Effects of Remimazolam |
| Date of disclosure of the study information | 2026/06/12 |
| Last modified on | 2026/06/12 13:00:38 |
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Basic information
Public title
A Study on the Amnesic Effects of Remimazolam
Acronym
A Study on the Amnesic Effects of Remimazolam
Scientific Title
A Study on the Amnesic Effects of Remimazolam
Scientific Title:Acronym
A Study on the Amnesic Effects of Remimazolam
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In cases of general anesthesia involving invasive procedures (such as epidural anesthesia or brachial plexus block), administering low-dose remimazolam as induction may reduce memories of anxiety and fear without compromising safety. This study examines its efficacy and appropriate administration methods.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Memory 1, 2, 3, 4, 5, 6, and 7 minutes after drug administration (assessed via questionnaire immediately after surgery and the following morning)
MOAA/S score
Blood pressure
Heart rate
SpO2
Numerican Rating Scale
Key secondary outcomes
NRS for Anxiety (Preoperative and Postoperative)
NRS for Satisfaction
Survey on whether you would prefer the same type of anesthesia for your next procedure
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After entering the operating room, the patient is fitted with a blood pressure monitor, an electrocardiogram, and a pulse oximeter, and an intravenous line is established.
Next, remimazolam is administered so that the concentration at the target site reaches 0.2 micro g/ml within 7 minutes of the administration of local anesthesia.
The predicted concentration at the target site 7 minutes after the start of administration is calculated using simulation software to determine the infusion rate.
Interventions/Control_2
Based on the EC95 obtained in Intervention 1, calculate the infusion rate using simulation software to determine the administration method that rapidly achieves the target effect site concentration with both single and continuous dosing.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients in good preoperative condition (ASA-PS 1 or 2) scheduled to undergo general anesthesia with local anesthesia
Key exclusion criteria
Dementia
History of benzodiazepine use
Remimazolam allergy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ogura |
Organization
Self-Defense Forces Central Hospital
Division name
Department of Anesthesiology
Zip code
154-8532
Address
1-2-24 Ikejiri, Setagaya-ku, Tokyo-to
TEL
03-3411-0151
ndmc4319guchi@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Okaguchi |
Organization
Self-Defense Forces Central Hospital
Division name
Department of Anesthesiology
Zip code
154-8532
Address
1-2-24 Ikejiri, Setagaya-ku, Tokyo-to
TEL
03-3411-0151
Homepage URL
ndmc4319guchi@gmail.com
Sponsor or person
Institute
Self-Defense Forces Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Self-Defense Forces Central Hospital
Address
1-2-24 Ikejiri, Setagaya-ku, Tokyo-to
Tel
03-3411-0151
clinic119-c-hosp@inet.gsdf.mod.go.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 | 06 | Month | 12 | 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
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | 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 | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069019
