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Withdrawn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
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring hydrodilation, general anesthetic
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.
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
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
We'll reach out to this number within 24 hrs