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WithdrawnNCT01378754Updated Oct 3, 2012

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

An interventional study of Fospropofol (Lusedra®) 6.5 and Fospropofol (Lusedra®) 10 in Interstitial Cystitis, sponsored by Grace Shih, MD. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-10-03.

Sponsored by Grace Shih, MD · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Loss of funding before enrollment.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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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®).

02

Conditions studied

  • Interstitial Cystitis

Keywords

  • hydrodilation
  • general anesthetic
03

In context

Cystitis

235 studies on the registry are indexed under Cystitis; 22 are open to participants now.

Browse Cystitis studies →

Lead sponsor

Grace Shih, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    6.5 milligram per kilogram of Fospropofol (Lusedra®)

    Drug: Fospropofol (Lusedra®) 6.5

  • Experimental
    10 milligram per kilogram of Fospropofol (Lusedra®)

    Drug: Fospropofol (Lusedra®) 10

  • Experimental
    12 milligram per kilogram of Fospropofol (Lusedra®)

    Drug: Fospropofol (Lusedra®) 12

Interventions

  • DrugFospropofol (Lusedra®) 6.5

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

  • DrugFospropofol (Lusedra®) 10

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

  • DrugFospropofol (Lusedra®) 12

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

06

What researchers measure

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.

    Time frame: 1 day

Secondary outcomes

  1. To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01378754
Lead sponsor
Grace Shih, MD
Responsible party
Grace Shih, MD (Associate Professor, University of Kansas Medical Center) — Sponsor-investigator
First posted
Jun 22, 2011
Start date
Jun 2011
Primary completion
May 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Oct 3, 2012

Study contacts

Grace Shih, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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