UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045195 |
|---|---|
| Receipt number | R000051635 |
| Scientific Title | Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2025/03/09 15:27:23 |
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Basic information
Public title
Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement
Acronym
Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement
Scientific Title
Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement
Scientific Title:Acronym
Retrospective observational study of the usefulness of Remimazolam in transcatheter aortic valve replacement
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of Remimazolam in anesthesia for transcatheter aortic valve implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time required for awakening
Key secondary outcomes
Hemodynamics during anesthesia
Procedure success rate of TAVI
Postoperative cognitive function
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 who underwent transcatheter aortic valve implantation at Kindai University Hospital during the study period.
Key exclusion criteria
Patients who cannot obtain their consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Nakao |
Organization
Kindai University Faculty of Medicine
Division name
Department of Anesthesiology and Critical Care
Zip code
5898511
Address
377-2 Ono-Higashi, Osaka-Sayama-city, Osaka, Japan
TEL
0723660221
anesth@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kitaura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Anesthesiology and Critical Care
Zip code
5898511
Address
377-2 Ono-Higashi, Osaka-Sayama-city, Osaka, Japan
TEL
0723660221
Homepage URL
https://www.med.kindai.ac.jp/anes/clinical_study.html
anesth@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai University
Address
377-2 Ono-Higashi, Osaka-Sayama-city, Osaka, Japan
Tel
0723660221
anesth@med.kindai.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
近畿大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-023-43895-0
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-43895-0
Number of participants that the trial has enrolled
152
Results
Among 258 MAC-TAVR patients, 253 were enrolled. After propensity score matching, 76 patients were assigned to each group. The time from end of drug-administration to arousal [20.0 (16.0, 24.0) min vs. 38.5 (30.0, 56.3) min, p < 0.0001] and the time from attempted-arousal to arousal [1.0 (1.0, 1.0) min vs. 12.5 (3.0, 26.8) min, p < 0.0001] were significantly shorter in the remimazolam group.
Results date posted
| 2025 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 23 | Day |
Baseline Characteristics
MAC-TAVR patients
Participant flow
retro
Adverse events
None
Outcome measures
arousal time, anesthesia time, intraoperative dose of noradrenarine, The length of ICU stay and hospitalization
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observation study. Consent acquisition will be an opt-out method. The evaluation items are extracted from the surgical support system (GAIA) and electronic medical records.
Management information
Registered date
| 2021 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051635
