UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022979
Receipt number R000026490
Scientific Title Efficacy of ramosetron in preventing postoperative nausea and vomiting: An updated meta-analysis with trial sequential analysis
Date of disclosure of the study information 2016/09/01
Last modified on 2018/01/01 10:43:11

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Basic information

Public title

Efficacy of ramosetron in preventing postoperative nausea and vomiting: An updated meta-analysis with trial sequential analysis

Acronym

Efficacy of ramosetron in preventing postoperative nausea and vomiting: An updated meta-analysis with trial sequential analysis

Scientific Title

Efficacy of ramosetron in preventing postoperative nausea and vomiting: An updated meta-analysis with trial sequential analysis

Scientific Title:Acronym

Efficacy of ramosetron in preventing postoperative nausea and vomiting: An updated 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 anti-PONV effects between ramosetron and placebo.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PON and POV between ramosetron and placebo in the early, late, and/or next day periods

Key secondary outcomes



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 a placebo 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.

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 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


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 09 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

2016 Year 12 Month 01 Day

Date analysis concluded

2017 Year 06 Month 01 Day


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=R000026490


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

Research case data specifications
Registered date File name

Research case data
Registered date File name