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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.
Decompensated congestive heart failure. Second and third degree heart block. 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Pre and Post Surgical Lymphocyte Counts

Outcome Description:

Lymphocyte counts determined by flow-cytometry and their function by cytotoxicity assays performed in the laboratory using samples obtained before and the morning after surgery. Patients who experience a reduction of less than 50% of their preoperative natural killer cell (NKC) activity considered as a success.

Outcome Time Frame:

2 days

Safety Issue:


Principal Investigator

Juan P. Cata, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Dexmedetomidine
  • Unilateral mastectomy
  • Blood sample collections
  • Immune system
  • White blood cell levels
  • Breast Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030