The Effect of Dexmedetomidine of the Immune System
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Dexmedetomidine |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Blood Draw Pre and Post Surgery
Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.
|
Drug: Dexmedetomidine
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in Houston, Texas.
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.
Contacts and Locations| Contact: Juan P. Cata, MD | 713-792-4582 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Juan P. Cata, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01692210 History of Changes |
| Other Study ID Numbers: | PA12-0524 |
| Study First Received: | September 19, 2012 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer Dexmedetomidine Unilateral mastectomy |
Blood sample collections Immune system White blood cell levels |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013