UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051875 |
|---|---|
| Receipt number | R000059184 |
| Scientific Title | Time to Extubation Comparison between Remimazolam Anesthesia Combined with Flumazenil and Propofol Anesthesia: A Single-Center Retrospective Observational Study |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2025/02/13 12:50:38 |
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Basic information
Public title
Time to Extubation Comparison between Remimazolam Anesthesia Combined with Flumazenil and Propofol Anesthesia: A Single-Center Retrospective Observational Study
Acronym
RMZ vs PROP in extubation
Scientific Title
Time to Extubation Comparison between Remimazolam Anesthesia Combined with Flumazenil and Propofol Anesthesia: A Single-Center Retrospective Observational Study
Scientific Title:Acronym
RMZ vs PROP in extubation
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare remimazolam and propofol anesthesia and ascertain whether there is a variance in the time interval between the surgical procedure's conclusion and the completion of extubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time interval between the surgical procedure's conclusion and the completion of extubation.
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
All patients who received general anesthesia during the study period
Key exclusion criteria
Administration of anesthetics other than remimazolam or propofol
Concomitant administration of remimazolam and propofol
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL
0534352738
alutena@gmail.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL
0534352738
Homepage URL
alutena@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Yuji Suzuki
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
Tel
0534352680
rinri@hama-med.ac.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
| 2023 | Year | 08 | Month | 10 | 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
314
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
| 2023 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center, retrospective, parallel-group propensity score-matched analysis study.
Patients undergoing surgery under general anesthesia at our institution during the one-year period from August 2020 - July 2021 will be included.
Extubation time, discharge time, patient characteristics, and other surgical-related information (e.g., position, site of surgery, duration of surgery, and type and amount of drugs used) will be investigated.
Management information
Registered date
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059184
