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

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01378754
• Other study ID #: 12588
• Status: Withdrawn
• Phase: N/A
• First received: June 8, 2011
• Last updated: October 2, 2012
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• Fospropofol (Lusedra®) 6.5
Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
• Fospropofol (Lusedra®) 10
Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
• Fospropofol (Lusedra®) 12
Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grace Shih, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).	To evaluate the use, dosing, efficacy and safety of fospropofol (Lusedra®) for the induction of general anesthesia using the laryngeal mask airway (LMA) in outpatient urology patients receiving hydrodilation therapy.	1 day	Yes
Secondary	To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)		1 day	Yes