UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054733 |
|---|---|
| Receipt number | R000062547 |
| Scientific Title | Comparison of Postoperative Nausea and Vomiting between Sedation with Remimazolam and Dexmedetomidine: A Single-Center Retrospective Observational Study |
| Date of disclosure of the study information | 2024/06/22 |
| Last modified on | 2025/03/09 15:37:10 |
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Basic information
Public title
Comparison of Postoperative Nausea and Vomiting between Sedation with Remimazolam and Dexmedetomidine: A Single-Center Retrospective Observational Study
Acronym
Comparison of Postoperative Nausea and Vomiting between Sedation with Remimazolam and Dexmedetomidine
Scientific Title
Comparison of Postoperative Nausea and Vomiting between Sedation with Remimazolam and Dexmedetomidine: A Single-Center Retrospective Observational Study
Scientific Title:Acronym
POSTREVOMIT study
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the Risk of Postoperative Nausea and Vomiting with Remimazolam Anesthesia in TAVI
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of PONV
Key secondary outcomes
Grade of PONV
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent TAVR under MAC with remimazolam or dexmedetomidine in our institution in the period from 2020 to 2024.
Key exclusion criteria
Patients opting out
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kitaura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
5898511
Address
377-2 Ohno Higashi, Osaka-Sayama city, Osaka, Japan
TEL
0723660221
kitaura@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
Zip code
5898511
Address
377-2 Ohno Higashi, Osaka-Sayama city, Osaka, Japan
TEL
0723660221
Homepage URL
kitaura@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Kindai University Faculty of Medicine
Address
377-2 Ohno-Higashi, Osaka-Sayama city, Osaka, Japan
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 | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/14/5/1759
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/14/5/1759
Number of participants that the trial has enrolled
122
Results
In TAVR with MAC and remimazolam, the incidence of PONV within 48 h was comparable to that of dexmedetomidine.
Results date posted
| 2025 | Year | 03 | Month | 09 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center retrospective observational study
Management information
Registered date
| 2024 | Year | 06 | Month | 22 | 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=R000062547
