The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pre and Post Surgical Lymphocyte Counts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Blood Draw Pre and Post Surgery
Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pre and Post Surgical Lymphocyte Counts
时间窗: 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.
次要结局
未报告次要终点