UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056446 |
|---|---|
| Receipt number | R000064504 |
| Scientific Title | Does ondansetron prevent intra-procedure nausea and vomiting in patients undergoing transcatheter aortic valve replacement with conscious sedation? |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2024/12/13 11:36:20 |
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Basic information
Public title
Does antiemetic ondansetron prevent intra-procedure nausea and vomiting in patients undergoing transcatheter aortic valve replacement with sedation?
Acronym
The effect of ondansetron on intra-procedure nausea and vomiting during transcatheter aortic valve replacement.
Scientific Title
Does ondansetron prevent intra-procedure nausea and vomiting in patients undergoing transcatheter aortic valve replacement with conscious sedation?
Scientific Title:Acronym
The effect of ondansetron on intra-procedure nausea and vomiting during transcatheter aortic valve replacement.
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate whether ondansetron reduces intra-procedure nausea and vomiting in patients undergoing transfemoral transcatheter aortic valve replacement with conscious sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was an incidence of intra-procedure nausea and vomiting during transfemoral transcatheter aortic valve replacement procedures.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing transfemoral transcatheter aortic valve replacement with conscious sedation
Key exclusion criteria
Patients who are converted to general anesthesia during the procedure or are unconscious
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kinoshita |
Organization
Hamamatsu University School of Medicine
Division name
Departments of Anesthesiology and Intensive Care
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2286
hkinoshi@krc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kinoshita |
Organization
Hamamatsu University School of Medicine
Division name
Departments of Anesthesiology and Intensive Care
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2286
Homepage URL
hkinoshi@krc.biglobe.ne.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
Toyohashi Heart Center
Address
Toyohashi Heart Center, 21-1 Gobutori, Ohyama-cho, Toyohashi, Aichi
Tel
0532-37-3377
hkinoshi@krc.biglobe.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
240301
Org. issuing International ID_1
Toyohashi Heart Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064504
