Clinical trial NCT00306722: An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy
Official title: A Phase 3, Randomized, Double-Blind, Dose-Controlled Study To Assess The Efficacy And Safety Of AQUAVAN® (Fospropofol Disodium) Injection For Minimal-To-Moderate Sedation In Patients Undergoing Flexible Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchoscopy
Anesthesia
Keywords: Bronchoscopy
Sedation
AQUAVAN
fospropofol disodium
Flexible bronchoscopy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.
3. Patient must be at least 18 years of age 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 Investigator.
4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
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: 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
measure: Completing the procedure
measure: Without requiring the use of alternative sedative medication
measure: Without requiring manual or mechanical ventilation
Secondary outcomes:
measure: 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
measure: Proportion of patients willing to be treated again with the same study sedative medication
measure: Proportion of patients who do not recall being awake during the procedure
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile, PC
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Health Science Campus (USC University Hospital)
state: California
city: Pensacola
country: United States
facility: Pensacola Research Consultants, Inc.
state: Florida
city: Augusta
country: United States
facility: Acute Care Consultants Inc.
state: Georgia
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Auburn
country: United States
facility: Central Maine Pulmonary Associates
state: Maine
city: Pittsfield
country: United States
facility: Berkshire Medical Center
state: Maryland
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Butte
country: United States
facility: Keith Popovich, MD, PLLC
state: Montana
city: Missoula
country: United States
facility: International Heart Institue of MT Foundation
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Johnson City
country: United States
facility: United Health Scrvices Hosptial, INC
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: ALL-TRIALS Clinical Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati, The University Hospital
state: Ohio
city: Charleston
country: United States
facility: Lowcountry Lung & Critical Care, PA
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Spartanburg
country: United States
facility: South Carolina Pharmaceutical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Galveston
country: United States
facility: The University of Texas Medical Branch Division of APICS
state: Texas
city: Abingdon
country: United States
facility: Johnston Memorial Hospital Pulmonary Research
state: Virginia
city: Fredericksburg
country: United States
facility: Pulmonary Associates of Fredericksburg, Inc.
state: Virginia
Study officials:
affiliation: Eisai Inc.
name: James Jones, MD, PharmD
role: STUDY_DIRECTOR
References:
citation: Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy. Chest. 2009 Jan;135(1):41-47. doi: 10.1378/chest.08-0623. Epub 2008 Jul 18.