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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022980
Receipt No. 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

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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
Email 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
Email miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute Kanagawa Children's Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026491

Research Plan
Registered date File name
2016/07/26 protocol_ramo_ondansetoron.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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