Very often patients receive medications 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. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
123
Precision Trials
Phoenix, Arizona, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Medical Research Institute, Inc.
Slidell, Louisiana, United States
Medical Research Institute
Slidell, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, United States
St. Louis Women's Healthcare Group
Chesterfield, Missouri, United States
International Heart Institute of Montana
Missoula, Montana, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, United States
...and 5 more locations
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
Time frame: 2 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.