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Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

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ClinicalTrials.gov Identifier: NCT01811199
Recruitment Status : Unknown
Verified March 2013 by A.Ozdemir Aktan, Marmara University.
Recruitment status was:  Active, not recruiting
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
A.Ozdemir Aktan, Marmara University

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

Condition or disease
Thyroid Cancer Breast Cancer

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels
Study Start Date : February 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis [ Time Frame: up to 3 days ]
    participants will be followed for the duration of hospital stay, till they are discharged in avarage 3 days for postoperative emesis.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing thyroidectomy and mastectomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811199


Locations
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Turkey
Marmara University School of Medicine
Istanbul, Turkey
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: A.Ozdemir Aktan, MD,prof Marmara University

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Responsible Party: A.Ozdemir Aktan, professor of surgery, Marmara University
ClinicalTrials.gov Identifier: NCT01811199     History of Changes
Other Study ID Numbers: 09.2011.0024
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by A.Ozdemir Aktan, Marmara University:
Thyroid cancer
Breast cancer
Dexamethasone
Emesis
Additional relevant MeSH terms:
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Thyroid Neoplasms
Postoperative Nausea and Vomiting
Neoplasms by Site
Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors