UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054251 |
|---|---|
| Receipt number | R000061952 |
| Scientific Title | Prospective comparative study of anesthesia with remimazolam versus conventional methods for TAVR |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/08/10 00:41:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective comparative study of anesthesia with remimazolam versus conventional methods for TAVR
Acronym
Prospective comparative study of anesthesia with remimazolam versus conventional methods for TAVR
Scientific Title
Prospective comparative study of anesthesia with remimazolam versus conventional methods for TAVR
Scientific Title:Acronym
PROREMIT
Region
| Japan |
Condition
Condition
aortic valve stenosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the usefulness of a remimazolam-based anesthesia in TAVR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to arousal
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Selection of anesthesia method
Remimazolam protocol
Interventions/Control_2
Selection of anesthesia method
Remimazolam protocol
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
18 years and older
With aortic valve stenosis
TF-TAVR under MAC
Consent can be obtained
Key exclusion criteria
Younger than 18 years
Non aortic valve stenosis
Non-TF TAVR
No consent
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kitaura |
Organization
Kindai University
Division name
Anesthesiology
Zip code
589-8511
Address
377-1 Ono-Higashi Osakasayama
TEL
0723660221
anesth@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kitaura |
Organization
Kindai University
Division name
Anesthesiologylogy
Zip code
589-8511
Address
377-2 Ono-Higashi Osakasayama
TEL
0723660221
Homepage URL
anesth@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
No funding
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
IRB of Kindai University Faculty of Medicine
Address
377-2 Ono-Higashi Osakasayama
Tel
0723660221
zizen@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
107
Results
The arousal time of remimazolam group was significantly shorter than one of dexmedetomidine group.
Results date posted
| 2025 | Year | 08 | Month | 10 | Day |
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 | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061952
