Institutional Review Board, Hospital for Special Surgery
July 27, 2010
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This study will assess the blood flow in the brain under hypotensive epidural anesthesia (HEA) for hip replacement. We aim to conduct a study to investigate if under HEA there is a difference in terms of cerebral blood flow using two different drugs to control blood pressure, called epinephrine and phenylephrine. The infusion of the drug will be randomized (similar to the toss of a coin) so each patient will receive one of the medication.
Cerebral blood flow will be measured with an ultrasound probe of the size of a pencil that will be placed on the side of patientís head just in front of the ear. The monitor will record the blood flow in a vessel of the brain. A total of 56 patients will be enrolled in the study (28 patients in each group). The enrollment period will be approximately 1 year. The patient will participate in the study for the duration of the surgery.
In the study will be included patients undergoing total hip replacement under hypotensive epidural anesthesia. Patients with specific cardiovascular diseases ( stenosis of the aortic valve, stenosis of the carotid artery, with a low heart rate and with cardiac conducting problems) or who take certain class of drugs ( amiodarone, beta-blockers) will be excluded from participating in the study.
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