UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046237 |
|---|---|
| Receipt number | R000052766 |
| Scientific Title | With ondansetron, comparison of propofol and remimazolam besilate for the prevention of postoperative nausea and vomiting. |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2024/06/02 19:44:02 |
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Basic information
Public title
With ondansetron, comparison of propofol and remimazolam besilate for the prevention of postoperative nausea and vomiting.
Acronym
With ondansetron, comparison of propofol and remimazolam besilate for the prevention of postoperative nausea and vomiting.
Scientific Title
With ondansetron, comparison of propofol and remimazolam besilate for the prevention of postoperative nausea and vomiting.
Scientific Title:Acronym
With ondansetron, comparison of propofol and remimazolam besilate for the prevention of postoperative nausea and vomiting.
Region
| Japan |
Condition
Condition
patients undergoing laparoscopic gynecologic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of ondansetron-propofol with ondansetron-remimazolam besilate for prevention of postoperative nausea and vomiting (PONV).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of the postoperative nausea and vomiting
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
General anesthesia with propofol.
Ondansetron was administered.
Interventions/Control_2
General anesthesia with remimazolam besilate.
Ondansetron was administered.
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
American Society of Anesthesiologists(ASA) physical status of I-III.
Key exclusion criteria
American Society of Anesthesiologists(ASA) physical status of IV-V.
Patients without consent.
Pregnant woman.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nami |
| Middle name | |
| Last name | Kakuta |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
7708503
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7181
kakuta.nami@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Nami |
| Middle name | |
| Last name | Kakuta |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
7708503
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7181
Homepage URL
kakuta.nami@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology,Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Tokushima
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical trail center for development al therapeutics
Address
2-50-1 Kuramoto, Tokushima
Tel
088-633-9294
awachiken@tokushima-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
| 2021 | Year | 11 | Month | 30 | 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
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 | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052766
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
