The Effect of Dexmedetomidine of the Immune System

M.D. Anderson Cancer Center20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

DexmedetomidineDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Pre and Post Surgical Lymphocyte Counts

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.

Time frame: 2 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.