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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bronchoscopy
- Sponsor
- Eisai Inc.
- Enrollment
- 250
- Locations
- 25
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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 of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.
- •Patient must be at least 18 years of age 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 Investigator.
- •Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day
- •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.
Outcomes
Primary Outcomes
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
Completing the procedure
Without requiring the use of alternative sedative medication
Without requiring manual or mechanical ventilation
Secondary Outcomes
- 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
- Proportion of patients willing to be treated again with the same study sedative medication
- Proportion of patients who do not recall being awake during the procedure