UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022980 |
|---|---|
| Receipt number | R000026491 |
| Scientific Title | Efficacy of ramosetron in preventing postoperative nausea and vomiting compared to ondansetron: A systematic review and meta-analysis with trial sequential analysis |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/01/01 10:44:28 |
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Basic information
Public title
Efficacy of ramosetron in preventing postoperative nausea and vomiting compared to ondansetron: A systematic review and meta-analysis with trial sequential analysis
Acronym
Efficacy of ramosetron in preventing postoperative nausea and vomiting compared to ondansetron: A systematic review and meta-analysis with trial sequential analysis
Scientific Title
Efficacy of ramosetron in preventing postoperative nausea and vomiting compared to ondansetron: A systematic review and meta-analysis with trial sequential analysis
Scientific Title:Acronym
Efficacy of ramosetron in preventing postoperative nausea and vomiting compared to ondansetron: A systematic review and meta-analysis with trial sequential analysis
Region
| Japan |
Condition
Condition
Patients who underwent surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to conduct systematic review to compare the effect on preventing PONV between ramosetron and ondansetron
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PON and/or POV between ramosetron and ondansetron in the early, late, and next day periods
Key secondary outcomes
rescue anti-emetics
side-effects of each drug
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all randomized controlled trials that tested the efficacy of ramosetron compared with ondansetron in the prophylaxis of PONV
Key exclusion criteria
studies which were reported by Fujii et al.
studies which did not include details of PON and/or POV.
We also exclude data from case reports, comments or letters to the editor, reviews, and animal studies.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL
045-711-2351
miharaxxxtotoro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL
045-711-2351
Homepage URL
miharaxxxtotoro@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Children's Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The details of the study protocol is attached.
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026491
