An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy
NCT ID: NCT00306722
Last Updated: 2008-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2006-04-30
2007-05-31
Brief Summary
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Detailed Description
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Following completion of preprocedure assessments, patients will be randomly assigned to 1 of 2 treatment groups at a 2:3 (AQUAVAN initial dose 1 \[2.0 mg/kg\]:AQUAVAN initial dose 2 \[6.5 mg/kg\] allocation ratio on the day of the scheduled procedure. Randomization will be stratified by site.
A person skilled in airway management (such as a respiratory therapist, a study nurse, or a clinician) and authorized by the facility in which the colonoscopy is performed must be immediately available during the conduct of the study. All patients will be placed on supplemental oxygen via nasal cannula (4 L/min), and an ECG monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of study medication. All patients will receive analgesic pretreatment (fentanyl citrate injection for pain; lidocaine for topical anesthetic followed by the administration of study medication. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit of sedation, and adverse events. Blood samples will be collected for PK analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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AQUAVAN® (fospropofol disodium) Injection
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Patient must be at least 18 years of age at the time of screening.
4. 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.
5. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
Exclusion Criteria
2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
3. 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.
4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
5. Patient has participated in an investigational drug study within 1 month prior to study start.
6. Patient is unwilling to adhere to pre- and postprocedural instructions.
7. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Principal Investigators
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James Jones, MD, PharmD
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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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
Countries
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References
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Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy. Chest. 2009 Jan;135(1):41-47. doi: 10.1378/chest.08-0623. Epub 2008 Jul 18.
Other Identifiers
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MGI 3000-0524
Identifier Type: -
Identifier Source: secondary_id
3000-0524
Identifier Type: -
Identifier Source: org_study_id