NCT01378754

Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia

A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Grace Shih, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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®).

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	Fospropofol (Lusedra®) 6.5	Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
DRUG	Fospropofol (Lusedra®) 10	Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
DRUG	Fospropofol (Lusedra®) 12	Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2011-06-22
• Last updated: 2012-10-03