A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
Interstitial cystitis is a condition where a defect in the protective lining of the bladder causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One way to help ease the symptoms of this disease is to fill the bladder full of water every 4 to 6 months.
Since this is a painful procedure an anesthesiologist will give you a drug that will make you unconscious for the procedure. General anesthesia can be given to you through an IV tube that is placed in a vein in your arm. There are only a few agents that induce sedation and these agents have certain disadvantages such as waking up slowly, low blood pressure, and pain at the injection site and a prolonged time to consciousness.
This study will be comparing doses of a new IV sedation induction agent drug to put you to sleep called fospropofol (Lusedra®).
Inclusion Criteria:
Male or female outpatients
-> 18-65 years of age,
weight 60-90 kg,
with an American Society of Anesthesiologists (ASA) physical status of P1 to P3 are eligible for enrollment.
Female patients of child bearing age will have a negative urine pregnancy test result and have used an acceptable method of birth control for >1 month prior to study enrollment.
Patients will be NPO >6 hours and scheduled for outpatient urological hydrodilation under general anesthesia.
Patients also will not be enrolled in another study or have received an experimental drug in the prior 30 days.
Exclusion criteria are: