A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

Procedural Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327392
• Other study ID #: 3000-0523
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 16, 2006
• Last updated: May 17, 2012
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2012
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Procedural Sedation

Intervention

Drug:
• AQUAVAN® (fospropofol disodium) Injection

Locations

Country	Name	City	State
United States	St. Louis Women's Healthcare Group	Chesterfield	Missouri
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Southern Orthopaedic Sports Medicine	Columbia	South Carolina
United States	Dallas VA Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	University of Louisville	Louisville	Kentucky
United States	International Heart Institute of Montana	Missoula	Montana
United States	Carolina Urologic Research	Myrtle Beach	South Carolina
United States	Chesapeake Research Group, LLC	Pasadena	Maryland
United States	Precision Trials	Phoenix	Arizona
United States	Hudson Valley Urology, PC	Poughkeepsie	New York
United States	Physicians' Research Options	Sandy	Utah
United States	Medical Research Institute	Slidell	Louisiana
United States	Medical Research Institute, Inc.	Slidell	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures		2 hours	Yes