UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054841 |
|---|---|
| Receipt number | R000062666 |
| Scientific Title | A retrospective observational study of the dose control method of the general anesthetic remimazolam, especially its use without reliance on an antagonist |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/12/30 10:28:19 |
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Basic information
Public title
A retrospective observational study of the dose control method of the general anesthetic remimazolam, especially its use without reliance on an antagonist
Acronym
Dose control method of remimazolam without reliance on an antagonist
Scientific Title
A retrospective observational study of the dose control method of the general anesthetic remimazolam, especially its use without reliance on an antagonist
Scientific Title:Acronym
Dose control method of remimazolam without reliance on an antagonist
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia with remimazolam
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Remimazolam, an ultrashort-acting benzodiazepine general anesthetic, is characterized by its minimal circulatory depression, rapid awakening from the end of administration, and the presence of an antagonist, flumazenil. Although it has been on the market for more than three years, there have been many case reports on the use of remimazolam in patients who were able to take advantage of its feature of minimal circulatory depression, and there have been no reports on the experience with its routine use. The purpose of this study is to clarify the appropriate use of remimazolam as the first choice of general anesthetics by retrospectively observing the experience with remimazolam. In particular, we will discuss the use of remimazolam without relying on an antagonist as much as possible, because an antagonist may cause patients to be re-sedated in the ward even if they are awake in the operating room. Rapid awakening is a reduction of anesthetic invasion for the patient and a contribution to operating room management for the medical facility. Avoidance of resedation is directly related to safety. This study is expected to serve as an important indicator for future anesthesia practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The appropriate use of remimazolam without relying on an antagonist
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia with remimazolam
Key exclusion criteria
Not applicable
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Koh |
| Middle name | |
| Last name | Mizutani |
Organization
Chibune Hospital
Division name
Department of Anestheisa
Zip code
555-0034
Address
3-2-39 Fukumachi, Nishiyodogawa-ku, Osaka
TEL
06-6471-9541
youshookme40@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koh |
| Middle name | |
| Last name | Mizutani |
Organization
Chibune Hospital
Division name
Department of Anesthesia
Zip code
555-0034
Address
3-2-39 Fukumachi, Nishiyodogawa-ku, Osaka
TEL
06-6471-9541
Homepage URL
youshookme40@yahoo.co.jp
Sponsor or person
Institute
Chibune Hospital
Institute
Department
Personal name
Funding Source
Organization
Chibune Hospital
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
Chibune Hospital
Address
3-2-39 Fukumachi, Nishiyodogawa-ku, Osaka
Tel
06-6471-9541
youshookme40@gmail.com
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
| 2024 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062666
