Interstitial CystitisNCT01378754
Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia
A study testing Fospropofol (Lusedra®) 6.5, Fospropofol (Lusedra®) 10 and Fospropofol (Lusedra®) 12 in people with Interstitial Cystitis, run by Grace Shih, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Fospropofol (Lusedra®) 6.5, Fospropofol (Lusedra®) 10 and Fospropofol (Lusedra®) 12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
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
- Being tested
- Fospropofol (Lusedra®) 6.5, Fospropofol (Lusedra®) 10, Fospropofol (Lusedra®) 12
- Keywords
- hydrodilation, general anesthetic
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fospropofol (Lusedra®) 6.5Drug
Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Fospropofol (Lusedra®) 10Drug
Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
Fospropofol (Lusedra®) 12Drug
Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
| Study group | Role | What they receive |
|---|---|---|
| 6.5 milligram per kilogram of Fospropofol (Lusedra®) | Experimental | Not described Receives: Drug: Fospropofol (Lusedra®) 6.5 |
| 10 milligram per kilogram of Fospropofol (Lusedra®) | Experimental | Not described Receives: Drug: Fospropofol (Lusedra®) 10 |
| 12 milligram per kilogram of Fospropofol (Lusedra®) | Experimental | Not described Receives: Drug: Fospropofol (Lusedra®) 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Loss of funding before enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Shih, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grace Shih, MD, University of Kansas Medical Center
- Investigators
- Grace Shih, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378754
- Sponsor's protocol ID
- 12588
- Status last verified
- Oct 2012
- First submitted
- 8 Jun 2011
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
- ClinicalTrials.gov ID
- NCT01378754
- Acronym / sponsor ID
- 12588
- Conditions
- Interstitial Cystitis
- Keywords
- hydrodilation, general anesthetic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of funding before enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Grace Shih, MDUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6.5 milligram per kilogram of Fospropofol (Lusedra®) | Experimental | Drug: Fospropofol (Lusedra®) 6.5 |
| 10 milligram per kilogram of Fospropofol (Lusedra®) | Experimental | Drug: Fospropofol (Lusedra®) 10 |
| 12 milligram per kilogram of Fospropofol (Lusedra®) | Experimental | Drug: Fospropofol (Lusedra®) 12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fospropofol (Lusedra®) 6.5Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV). | Drug | 6.5 milligram per kilogram of Fospropofol (Lusedra®) |
| Fospropofol (Lusedra®) 10Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV). | Drug | 10 milligram per kilogram of Fospropofol (Lusedra®) |
| Fospropofol (Lusedra®) 12Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV). | Drug | 12 milligram per kilogram of Fospropofol (Lusedra®) |
Primary outcome
To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).
Time frame: 1 day
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 secondary outcome
To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Shih, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Fospropofol (Lusedra®) 6.5, Fospropofol (Lusedra®) 10 and Fospropofol (Lusedra®) 12 in people with Interstitial Cystitis, run by Grace Shih, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA). (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.