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

Primary Purpose

Interstitial Cystitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fospropofol (Lusedra®) 6.5
Fospropofol (Lusedra®) 10
Fospropofol (Lusedra®) 12
Sponsored by
Grace Shih, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring hydrodilation, general anesthetic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    6.5 milligram per kilogram of Fospropofol (Lusedra®)

    10 milligram per kilogram of Fospropofol (Lusedra®)

    12 milligram per kilogram of Fospropofol (Lusedra®)

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)

    Full Information

    First Posted
    June 8, 2011
    Last Updated
    October 2, 2012
    Sponsor
    Grace Shih, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01378754
    Brief Title
    Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia
    Official Title
    A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Loss of funding before enrollment.
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    June 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Grace Shih, MD

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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®).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Cystitis
    Keywords
    hydrodilation, general anesthetic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    6.5 milligram per kilogram of Fospropofol (Lusedra®)
    Arm Type
    Experimental
    Arm Title
    10 milligram per kilogram of Fospropofol (Lusedra®)
    Arm Type
    Experimental
    Arm Title
    12 milligram per kilogram of Fospropofol (Lusedra®)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Fospropofol (Lusedra®) 6.5
    Intervention Description
    Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
    Intervention Type
    Drug
    Intervention Name(s)
    Fospropofol (Lusedra®) 10
    Intervention Description
    Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
    Intervention Type
    Drug
    Intervention Name(s)
    Fospropofol (Lusedra®) 12
    Intervention Description
    Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
    Primary Outcome Measure Information:
    Title
    To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).
    Description
    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.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Grace Shih, MD
    Organizational Affiliation
    University of Kansas Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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