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

Grace Shih, MD

Status: Withdrawn

Conditions: Interstitial Cystitis

Treatments: Drug: Fospropofol (Lusedra®) 12; Drug: Fospropofol (Lusedra®) 6.5; Drug: Fospropofol (Lusedra®) 10

Study type: Interventional

Funder types: Other

Identifiers

NCT01378754

12588

Details and patient eligibility

About

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®).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

6.5 milligram per kilogram of Fospropofol (Lusedra®)

Experimental group

Treatment:

Drug: Fospropofol (Lusedra®) 6.5

10 milligram per kilogram of Fospropofol (Lusedra®)

Experimental group

Treatment:

Drug: Fospropofol (Lusedra®) 10

12 milligram per kilogram of Fospropofol (Lusedra®)

Experimental group

Treatment:

Drug: Fospropofol (Lusedra®) 12