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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003822
Receipt No. R000004606
Scientific Title Premedication with mirtazapine reduces postoperative nausea and vomiting.
Date of disclosure of the study information 2010/06/25
Last modified on 2012/04/05

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Basic information
Public title Premedication with mirtazapine reduces postoperative nausea and vomiting.
Acronym Mirtazapine and PONV
Scientific Title Premedication with mirtazapine reduces postoperative nausea and vomiting.
Scientific Title:Acronym Mirtazapine and PONV
Region
Japan

Condition
Condition postoperative nausea and vomiting
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Could premadication with mirtazapine reduce the risk of postoperative nausea and vomiting?
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The severity of nausea and the times of vomiting in 24hr after the surgery.
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 Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Placebo group: patient takes placebo 1hr before the surgery
Interventions/Control_2 Mirtazapine: paient takes mirtazapine 30mg before the surgery
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
75 years-old >=
Gender Male and Female
Key inclusion criteria patients with open gastrointestinal surgery
ASA-PS 1,2
Apfel scoring 2<
Key exclusion criteria emergency surgery.
patients with hypersensitivity to mirtazapine,taking any other antidepressant drugs or steroids, taking antiemetics within 24hr.
patients who cannot do VAS.

Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kayo Takimoto
Organization Ikeda City Hospital
Division name Department of Anesthesiology
Zip code
Address 3-1-18, Jyonan, Ikeda City
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Ikeda City Hospital
Division name Department of Anesthesiology
Zip code
Address
TEL 072-754-6670
Homepage URL
Email

Sponsor
Institute Ikeda City Hospital,Department of Anesthesiology
Institute
Department

Funding Source
Organization Ikeda City Hospital
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 市立池田病院

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 25 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
2010 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 25 Day
Last modified on
2012 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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