The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery
Drug Data
Collected from today forward - ProspectiveBreast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas MD Anderson Cancer Center
Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps