Study Stopped
Loss of funding before enrollment.
Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia
A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
1 other identifier
interventional
N/A
0 countries
N/A
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®).
Trial Health
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Started Jun 2011
Typical duration for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 3, 2012
October 1, 2012
2.9 years
June 8, 2011
October 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)
1 day
Study Arms (3)
6.5 milligram per kilogram of Fospropofol (Lusedra®)
EXPERIMENTAL10 milligram per kilogram of Fospropofol (Lusedra®)
EXPERIMENTAL12 milligram per kilogram of Fospropofol (Lusedra®)
EXPERIMENTALInterventions
Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Women who are breast feeding would also be excluded from participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grace Shih, MDlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grace Shih, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 22, 2011
Study Start
June 1, 2011
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
October 3, 2012
Record last verified: 2012-10