Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2012-09-30
2015-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Blood Draw Pre and Post Surgery
Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
3.2.2 - 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.
18 Years
FEMALE
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Juan P. Cata, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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PA12-0524
Identifier Type: -
Identifier Source: org_study_id
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