UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063198 |
|---|---|
| Receipt number | R000072132 |
| Scientific Title | Safety of Remimazolam-Based General Anesthesia in Patients Receiving Long-Term Benzodiazepine Therapy |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 06:10:50 |
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Basic information
Public title
Evaluation of the Safety of Remimazolam in Patients Receiving Long-Term Benzodiazepine Therapy
Acronym
ReBen-Safe Study
Scientific Title
Safety of Remimazolam-Based General Anesthesia in Patients Receiving Long-Term Benzodiazepine Therapy
Scientific Title:Acronym
Remimazolam Safety in Long-Term Benzodiazepine Users - ReBen-Safe Study
Region
| Japan |
Condition
Condition
Surgical patients receiving long-term benzodiazepine therapy who are scheduled for general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients receiving long-term benzodiazepine therapy, tolerance may lead to an unpredictable anesthetic response to remimazolam, potentially resulting in increased dose requirements and delayed emergence. Furthermore, reversal with flumazenil requires caution because it may precipitate withdrawal symptoms, agitation, or hyperventilation.
Hybrid total intravenous anesthesia (Hybrid TIVA), combining remimazolam and propofol, may reduce the required doses and effect-site concentrations of both agents. This approach may consequently minimize prolonged anesthetic effects and reduce the need for flumazenil.
This prospective study aims to evaluate the safety and effectiveness of Hybrid TIVA with remimazolam and propofol in patients receiving long-term benzodiazepine therapy. The study will assess the reliability of anesthetic induction and maintenance, time to emergence, frequency of flumazenil administration, and perioperative adverse events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to emergence, estimated effect-site concentrations, BIS waveforms, spectral edge frequency 95% (SEF95), presence or absence of intraoperative awareness, and postoperative agitation. Resedation is defined as the loss of response to verbal commands after initial emergence.
Key secondary outcomes
Incidence of intraoperative awareness assessed within 24 hours after surgery
Incidence of postoperative agitation from emergence to 120 minutes after flumazenil administration
Estimated effect-site concentrations of remimazolam and propofol at loss of response to verbal commands
Estimated effect-site concentrations of remimazolam and propofol during stable maintenance of anesthesia
Estimated effect-site concentrations of remimazolam and propofol at recovery of response to verbal commands
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients receiving benzodiazepine.
Key exclusion criteria
Patients with an ASA physical status of III or higher were excluded.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | SATORU |
| Middle name | |
| Last name | ASANO |
Organization
Japanese Red Cross Medical Center
Division name
Dept of Anesthesiology
Zip code
150-0012
Address
Shibuya-ku Hiroo 4-1-22, Tokyo
TEL
03-3400-1311
asanosatoru@kke.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | SATORU |
| Middle name | |
| Last name | ASANO |
Organization
Japanese Red Cross Medical Center
Division name
Dept of Anesthesiology
Zip code
150-0012
Address
Shibuya-ku Hiroo 4-1-22, Tokyo
TEL
03-3400-1311
Homepage URL
asanosatoru@kke.biglobe.ne.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
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
Japanese Red Cross Medical Center
Address
Shibuya-ku Hiroo 4-1-22
Tel
03-3400-1311
N/A
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 | 10 | Month | 07 | 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
3
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study in patients who regularly use benzodiazepines and receive general anesthesia with combined remimazolam and propofol as part of routine clinical care. The primary outcome is whether adequate sedation is achieved. The secondary outcome is the presence or absence of postoperative agitation. The anesthetic technique is determined by clinical judgment independently of study participation.
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072132
