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

• Status: Withdrawn
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grace Shih, MD
• Treatments: Fospropofol; Propofol

Criteria

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:

• hypersensitivity or allergy to any anesthesia, opioids, benzodiazepines or any drugs used in the study, failure to meet NPO status or an abnormal, clinically significant ECG finding.

• Another exclusion is the presence of a difficult airway that would prevent use of the laryngeal mask airway (LMA) or successful LMA insertion.

• Women who are breast feeding would also be excluded from participation.