A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Procedural Sedation |
Drug: AQUAVAN® (fospropofol disodium) Injection |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures |
- Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 123 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Number of sites/patients: Approximately 18 sites and 125 patients.
Inclusion Criteria:
- 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 (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures 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.
Exclusion Criteria:
- 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 Principal Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
- 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.
Contacts and Locations| United States, Arizona | |
| Precision Trials | |
| Phoenix, Arizona, United States, 85032 | |
| United States, Florida | |
| Borland-Groover Clinic | |
| Jacksonville, Florida, United States, 32256 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Medical Research Institute, Inc. | |
| Slidell, Louisiana, United States, 70458 | |
| Medical Research Institute | |
| Slidell, Louisiana, United States, 70458 | |
| United States, Maryland | |
| Chevy Chase Clinical Research | |
| Chevy Chase, Maryland, United States, 20815 | |
| Chesapeake Research Group, LLC | |
| Pasadena, Maryland, United States, 21122 | |
| United States, Missouri | |
| St. Louis Women's Healthcare Group | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Montana | |
| International Heart Institute of Montana | |
| Missoula, Montana, United States, 59802 | |
| United States, New York | |
| Hudson Valley Urology, PC | |
| Poughkeepsie, New York, United States, 12601 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, South Carolina | |
| Southern Orthopaedic Sports Medicine | |
| Columbia, South Carolina, United States, 29204 | |
| Carolina Urologic Research | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Texas | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States, 75216 | |
| United States, Utah | |
| Physicians' Research Options | |
| Sandy, Utah, United States, 84070 | |
| Study Director: | James B Jones, MD, PharmD | Eisai Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00327392 History of Changes |
| Other Study ID Numbers: | 3000-0523 |
| Study First Received: | May 16, 2006 |
| Results First Received: | March 1, 2012 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eisai Inc.:
|
Arthroscopy AV Shunt Bunion Dilatation and Curettage Esophagogastroduodenoscopy Hysteroscopy |
Lithotripsy Rotator Cuff/ Shoulder Transesophageal Echocardiography Ureteroscopy AQUAVAN Sedation |
Additional relevant MeSH terms:
|
Fospropofol disodium Propofol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on June 18, 2013