MedDataX Logo

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

NCT ID: NCT01378754

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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®).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Cystitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hydrodilation general anesthetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

6.5 milligram per kilogram of Fospropofol (Lusedra®)

Group Type EXPERIMENTAL

Fospropofol (Lusedra®) 6.5

Intervention Type DRUG

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

10 milligram per kilogram of Fospropofol (Lusedra®)

Group Type EXPERIMENTAL

Fospropofol (Lusedra®) 10

Intervention Type DRUG

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

12 milligram per kilogram of Fospropofol (Lusedra®)

Group Type EXPERIMENTAL

Fospropofol (Lusedra®) 12

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fospropofol (Lusedra®) 6.5

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

Intervention Type DRUG

Fospropofol (Lusedra®) 10

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

Intervention Type DRUG

Fospropofol (Lusedra®) 12

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Grace Shih, MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Grace Shih, MD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grace Shih, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12588

Identifier Type: -

Identifier Source: org_study_id