Clinical trial NCT01692210: The Effect of Dexmedetomidine of the Immune System
Official title: The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Dexmedetomidine
Unilateral mastectomy
Blood sample collections
Immune system
White blood cell levels
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2012-09-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in Houston, Texas.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre and Post Surgical Lymphocyte Counts
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juan P. Cata, MD
role: PRINCIPAL_INVESTIGATOR
References: