The Effect of Dexmedetomidine of the Immune System
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery|
- Pre and Post Surgical Lymphocyte Counts [ Time Frame: 2 days ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
15cc of blood drawn prior or at the moment of anesthesia induction and the morning after surgery.
|Study Start Date:||September 2012|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Blood Draw Pre and Post Surgery
Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.
After induction of general anesthesia, a loading dose of dexmedetomidine (1 mcg/kg) given in 15 min followed by an infusion of the same medication at a rate of 0.4 - 0.7 mcg/kg/hour.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692210
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Juan P. Cata, MD||M.D. Anderson Cancer Center|