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Loss of funding before enrollment.
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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®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6.5 milligram per kilogram of Fospropofol (Lusedra®) | Experimental |
| |
| 10 milligram per kilogram of Fospropofol (Lusedra®) | Experimental |
| |
| 12 milligram per kilogram of Fospropofol (Lusedra®) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol (Lusedra®) 6.5 | Drug | Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV). |
|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA) | 1 day |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Shih, MD | University of Kansas Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
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| Fospropofol (Lusedra®) 10 | Drug | Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV). |
|
| Fospropofol (Lusedra®) 12 | Drug | Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV). |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |