- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811199
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels
March 12, 2013 updated by: A.Ozdemir Aktan, Marmara University
Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.
Study Overview
Status
Unknown
Conditions
Detailed Description
This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated.
In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Marmara University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing thyroidectomy and mastectomy
Description
Inclusion Criteria:
- breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent
Exclusion Criteria:
- ones who did not sign the consent form NSAID or steroid users
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis
Time Frame: up to 3 days
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participants will be followed for the duration of hospital stay, till they are discharged in avarage 3 days for postoperative emesis.
|
up to 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: A.Ozdemir Aktan, MD,prof, Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (ANTICIPATED)
April 1, 2013
Study Completion (ANTICIPATED)
May 1, 2013
Study Registration Dates
First Submitted
March 6, 2013
First Submitted That Met QC Criteria
March 12, 2013
First Posted (ESTIMATE)
March 14, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 14, 2013
Last Update Submitted That Met QC Criteria
March 12, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2011.0024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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