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

October 2, 2012 updated by: Grace Shih, MD

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®).

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6.5 milligram per kilogram of Fospropofol (Lusedra®)
Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Experimental: 10 milligram per kilogram of Fospropofol (Lusedra®)
Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Experimental: 12 milligram per kilogram of Fospropofol (Lusedra®)
Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).
Time Frame: 1 day
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

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Grace Shih, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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