The Effect of Dexmedetomidine of the Immune System

NCT ID: NCT01692210

Last Updated: 2016-01-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

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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