The Effect of Dexmedetomidine of the Immune System



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2012
End Date:February 2015

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The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery

The goal of this research study is to learn about how dexmedetomidine (a standard of care
sedative) affects your immune system (your defenses against cancer) by measuring your white
blood cell levels before and after surgery.

Dexmedetomidine is a type of sedative used as part of anesthetic care. It is sometimes used
to help lower the amount of pain killers and other anesthetics that are given to a patient
during surgery. Researchers want to study how this drug works in cancer patients and review
the patient's chart for pain levels and medication use after surgery. Part of this research
involves studying the immune system of surgery patients.

If you agree to take part in this study, blood (about 1 tablespoon) will be drawn before you
have surgery and the morning after surgery while you are still in the hospital. This blood
will be used to learn more about how your immune system works.

After your second blood draw, your participation in this study will be over.

This is an investigational study.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

3.1.1 - Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer
Center.

3.1.2 - Patients 18 years of age and older. There will be no upper age restriction.

3.1.3 - Patients must sign a study-specific consent form.

Exclusion Criteria:

3.2.1 - ASA 4

3.2.2 - Contraindication to the use of dexmedetomidine.

3.2.2.1. Decompensated congestive heart failure.

3.2.2.2. Second and third degree heart block.

3.2.2.2. Known allergy to dexmedetomidine or any of the medications used in the study

3.2.3 - Patients taking clonidine for treatment of arterial hypertension.

3.2.4 - Patients that are pregnant.

3.2.5 - Patients taking opioids at the time of surgery.

3.2.6 - Patients having plastic surgical reconstruction.

3.2.7 - Recent chemotherapy (< 4 weeks).

3.2.8 - Active autoimmune or immunological disease including but not limited to systemic
lupus erythematous, rheumatoid arthritis and Sjogren's disease

3.2.9 - Patient refusal to participate in the study.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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