The Effect of Dexmedetomidine of the Immune System

NCT01692210

Last updated date
Study Location
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title The Effect of Dexmedetomidine of the Immune System
Official Title The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
15cc of blood drawn prior or at the moment of anesthesia induction and the morning after surgery.
Sampling Method Probability Sample
Study Population Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in Houston, Texas.
Condition Breast Cancer
Intervention 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.
Study Groups/Cohorts Blood Draw Pre and Post Surgery
Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.
Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2012)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01692210
Other Study ID Numbers PA12-0524
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator:Juan P. Cata, MDM.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date January 2016