Clinical trial NCT00327392: A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Procedural Sedation
Keywords: Arthroscopy
AV Shunt
Bunion
Dilatation and Curettage
Esophagogastroduodenoscopy
Hysteroscopy
Lithotripsy
Rotator Cuff/ Shoulder
Transesophageal Echocardiography
Ureteroscopy
AQUAVAN
Sedation
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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 criteria: - Number of sites/patients: Approximately 18 sites and 125 patients.

Inclusion Criteria:

1. Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
2. 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.
3. Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures 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:

1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
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 Principal Investigator.
4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
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.

Primary outcomes:
measure: Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Slidell
country: United States
facility: Medical Research Institute, Inc.
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Pasadena
country: United States
facility: Chesapeake Research Group, LLC
state: Maryland
city: Chesterfield
country: United States
facility: St. Louis Women's Healthcare Group
state: Missouri
city: Missoula
country: United States
facility: International Heart Institute of Montana
state: Montana
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research
state: South Carolina
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Sandy
country: United States
facility: Physicians' Research Options
state: Utah
Study officials:
affiliation: Eisai Inc.
name: James B Jones, MD, PharmD
role: STUDY_DIRECTOR
References: