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

NCT01378754 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-10-03

No results posted yet for this study

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®).

Conditions

  • Interstitial Cystitis

Interventions

DRUG

Fospropofol (Lusedra®) 6.5

Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).

DRUG

Fospropofol (Lusedra®) 10

Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).

DRUG

Fospropofol (Lusedra®) 12

Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).

Sponsors & Collaborators

  • Grace Shih, MD

    lead OTHER

Principal Investigators

  • Grace Shih, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-05-31
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01378754 on ClinicalTrials.gov