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Adult Trials: 18+ Years
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.
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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| 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 | 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 |
| |||
| 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 |
| |||
| PRS Account | M.D. Anderson Cancer Center | |||
| Verification Date | January 2016 | |||