An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy
- Conditions
- BronchoscopyAnesthesia
- Registration Number
- NCT00306722
- Lead Sponsor
- Eisai Inc.
- Brief Summary
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.
- Detailed Description
This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6.5 mg/kg compared to a minimally effective dose of AQUAVAN 2.0 mg/kg, both following pretreatment with an analgesic, fentanyl in patients who are undergoing flexible bronchoscopy.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sedation Success rate is defined as: Having 3 consecutive Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale scores of ≤4 after administration of sedative medication Completing the procedure Without requiring the use of alternative sedative medication Without requiring manual or mechanical ventilation
- Secondary Outcome Measures
Name Time Method Treatment Success rate - Treatment Success is defined as a patient (i) completing the procedure (ii) without requiring alternative sedative medications AND (iii) without requiring manual or mechanical ventilation Proportion of patients willing to be treated again with the same study sedative medication Proportion of patients who do not recall being awake during the procedure
Trial Locations
- Locations (25)
Pulmonary Associates of Mobile, PC
🇺🇸Mobile, Alabama, United States
Saddleback Memorial Medical Center
🇺🇸Laguna Hills, California, 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
Pulmonary Associates of Fredericksburg, Inc.
🇺🇸Fredericksburg, Virginia, United States
The University of Texas Medical Branch Division of APICS
🇺🇸Galveston, Texas, United States
South Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
University of Cincinnati, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Pensacola Research Consultants, Inc.
🇺🇸Pensacola, Florida, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
United Health Scrvices Hosptial, INC
🇺🇸Johnson City, New York, United States
USC Health Science Campus (USC University Hospital)
🇺🇸Los Angeles, California, United States
Central Maine Pulmonary Associates
🇺🇸Auburn, Maine, United States
Lowcountry Lung & Critical Care, PA
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Berkshire Medical Center
🇺🇸Pittsfield, Maryland, United States
Acute Care Consultants Inc.
🇺🇸Augusta, Georgia, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
ALL-TRIALS Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Johnston Memorial Hospital Pulmonary Research
🇺🇸Abingdon, Virginia, United States