An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy

Completed · Phase 3

Conditions studied: Bronchoscopy, Anesthesia

In brief

Very often patients receive medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild-to-moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol with a longer duration of effect.

Key facts

Study ID

NCT00306722

Run by

Eisai Inc.

People needed

250

Starts

2006-04-01

Expected to finish

2007-05-01

Last updated by the study team

2008-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures
• Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.
• Patient must be at least 18 years of age at the time of screening.
• If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose.
• Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.

You may not qualify if…

• Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
• Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
• Patient has a Mallampati Classification Score of 4; OR a Mallampati Classification Score of 3 AND a thyromental distance ≤4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator.
• Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
• Patient has participated in an investigational drug study within 1 month prior to study start.
• Patient is unwilling to adhere to pre- and postprocedural instructions.
• Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.

Where it is running

• Pulmonary Associates of Mobile, PC — Mobile, Alabama, United States
• Precision Trials — Phoenix, Arizona, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• USC Health Science Campus (USC University Hospital) — Los Angeles, California, United States
• Pensacola Research Consultants, Inc. — Pensacola, Florida, United States
• Acute Care Consultants Inc. — Augusta, Georgia, United States
• Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
• Central Maine Pulmonary Associates — Auburn, Maine, United States
• Berkshire Medical Center — Pittsfield, Maryland, United States
• Hurley Medical Center — Flint, Michigan, United States
• Keith Popovich, MD, PLLC — Butte, Montana, United States
• International Heart Institue of MT Foundation — Missoula, Montana, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• United Health Scrvices Hosptial, INC — Johnson City, New York, United States
• Brody School of Medicine — Greenville, North Carolina, United States
• ALL-TRIALS Clinical Research, LLC — Winston-Salem, North Carolina, United States
• University of Cincinnati, The University Hospital — Cincinnati, Ohio, United States
• Lowcountry Lung & Critical Care, PA — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• South Carolina Pharmaceutical Research — Spartanburg, South Carolina, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• The University of Texas Medical Branch Division of APICS — Galveston, Texas, United States
• Johnston Memorial Hospital Pulmonary Research — Abingdon, Virginia, United States
• Pulmonary Associates of Fredericksburg, Inc. — Fredericksburg, Virginia, United States

Full record on ClinicalTrials.gov

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