UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047892 |
|---|---|
| Receipt number | R000054600 |
| Scientific Title | Remimazolam versus sevofulrane for transcatheter aortic valve implantation; a randomized open label trial |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2026/08/05 10:07:20 |
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Basic information
Public title
Remimazolam versus sevofulrane for transcatheter aortic valve implantation; a randomized open label trial
Acronym
Remimazolam versus sevofulrane for TAVI
Scientific Title
Remimazolam versus sevofulrane for transcatheter aortic valve implantation; a randomized open label trial
Scientific Title:Acronym
Remimazolam versus sevofulrane for TAVI
Region
| Japan |
Condition
Condition
Severe aortic stenosis
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of remimazolam or sevoflurane in emergence time from general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Emergence time from general anesthesia (time between cessation of anesthetics and extubation)
Key secondary outcomes
1. Blood pressure, heart rate, SpO2 during general anesthesia
2. Doses of vasopressors during general anesthesia
3. Intra- and post-operative comprications
4. Respond to verbal stimuli, recovery of muscle strength (tidal volume, and strong hand grip)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using remimazolam as a sedative for general anesthesia
Interventions/Control_2
Using sevoflurane and midazolam as sedatives for general anesthesia
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
Severe aortic stenosis
Key exclusion criteria
1. Allergic to remimazolam, sevoflurane, midazolam, or flumazenil
2. Past history or family history of malignant hyperthermia
3. Patients with difficulties for participation due to psychologic conditions
4. Patients who are not considered to be feasible
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Godai |
Organization
Kagoshima University
Division name
Department of Anesthesiology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755430
kouhei84@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Godai |
Organization
Kagoshima University
Division name
Department of Anesthesiology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755430
Homepage URL
kouhei84@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
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
Kagoshima University Hospital Clinical Research Management Center
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s12630-024-02899-8
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s12630-024-02899-8
Number of participants that the trial has enrolled
60
Results
The median time to extubation was significantly shorter in the remimazolam group than in the sevoflurane group.
Results date posted
| 2026 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients were aged 75 yr, and over half were female. All patients underwent transfemoral TAVI.
Participant flow
During the study period, 68 patients underwent TAVI, with 60 patients enrolled in the study. Two patients in the remimazolam group did not undergo intervention because of changes in the surgical plan. In the sevoflurane group, the intervention was not initiated for one patient as only verbal consent was obtained, and the intervention was discontinued for another patient because other sedatives were used.
Adverse events
There were no intraoperative VARC-3 complications in either group.
Outcome measures
The time to extubation was significantly shorter in the remimazolam group compared with the sevoflurane group. The median ephedrine bolus dose was lower in the remimazolam group than in the sevoflurane group. There were no significant differences in other secondary outcomes between the groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 11 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 11 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 30 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054600
