UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003822 |
|---|---|
| Receipt number | 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 12:00:04 |
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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
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
Sponsor or person
Institute
Ikeda City Hospital,Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004606
