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NCT01811199 Clinical Trial

Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

Breast Cancer Clinical Trial

Official title:
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01811199
Other study ID # 09.2011.0024
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 6, 2013
Last updated March 12, 2013
Start date February 2011
Est. completion date May 2013

Study information
Verified date March 2013
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date May 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Marmara University School of Medicine Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis 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 Yes
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