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First published online on July 18, 2008
Chest, doi:10.1378/chest.08-0623
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Right arrow Articles by Silvestri, G. A.
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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

Gerard A. Silvestri, MD, FCCP1; Brad D. Vincent, MD1; Momen M. Wahidi, MD2; Emory Robinette, MD, FCCP3; James R. Hansbrough, MD4 and Gordon H. Downie, MD, PhD, FCCP5

1Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC, bradvincent@msn.com 2Duke University School of Medicine, Durham, NC, momen.wahidi@duke.edu 3Johnston Memorial Hospital Pulmonary Research, Abingdon, VA, jmhpr@comcast.net 4Graves-Gilbert Clinic, Bowling Green, KY, hansbroughj@ggclinic.com 5Brody School of Medicine, East Carolina University, Greenville, NC, downieg@ecu.edu

silvestri{at}musc.edu

Abstract

BackgroundFospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated fospropofol in patients undergoing flexible bronchoscopy.

MethodsPatients ≥18 years were randomized (2:3) to fospropofol 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl 50 mcg. Supplemental doses of each were given per protocol. The primary endpoint was sedation success: 3 consecutive MOAA/S scores ≤4 plus procedure completion without alternative sedative medication and/or mechanical ventilation. Other endpoints included treatment success, patient/physician satisfaction, and safety.

ResultsOf 252 patients, 150 were randomized to receive 6.5 mg/kg fospropofol; 102, to receive 2 mg/kg. Sedation success rates were 88.7% and 27.5%, respectively (P<.0001). Treatment successes (91.3% versus 41.2%; P<.001), willingness to be treated again (94.6% versus 78.2%; P<.001), and absence of procedural recall (83.3% versus 55.4%; P<.001) were significantly better with 6.5 mg/kg. Median time to fully alert was slightly longer for 6.5 mg/kg (5.5 versus 3.0 minutes). Proportion of patients requiring supplemental analgesics (16.7% versus 37.3%), and use of alternative sedative medications (8.0% versus 58.8%) were lower for patients in the 6.5 mg/kg group (all comparisons, P<0.001). The most frequent adverse events were transient and self-limited paresthesias and pruritus of mild to moderate severity. Hypoxemia (predominantly mild to moderate) was the most common sedation-related adverse event and occurred in 15.4% and 12.6% of patients in the 6.5 mg/kg and 2 mg/kg fospropofol groups, respectively.

ConclusionsFospropofol provided safe and effective sedation for patients undergoing flexible bronchoscopy.

Trial registry nameAn Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy

Trial registration numberNCT00306722

Key Words: Aquavan • bronchoscopy • conscious sedation • fospropofol disodium






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