The Effect of Dexmedetomidine of the Immune System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01692210|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : January 7, 2016
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Dexmedetomidine|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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.
- Pre and Post Surgical Lymphocyte Counts [ Time Frame: 2 days ]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
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): 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|