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Original Research |

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, FCCP*; Brad D. Vincent, MD, FCCP; Momen M. Wahidi, MD, FCCP; Emory Robinette, MD, FCCP; James R. Hansbrough, MD, FCCP; Gordon H. Downie, MD, PhD, FCCP
Author and Funding Information

*From the Division of Pulmonary and Critical Care Medicine (Drs. Silvestri and Vincent), Medical University of South Carolina, Charleston, SC; Duke University School of Medicine (Dr. Wahidi), Durham, NC; Pulmonary Research (Dr. Robinette), Johnston Memorial Hospital, Abingdon, VA; Graves-Gilbert Clinic (Dr. Hansbrough), Bowling Green, KY; and the Brody School of Medicine (Dr. Downie), East Carolina University, Greenville, NC.

Correspondence to: Gerard A. Silvestri, MD, FCCP, Department of Pulmonary and Critical Care Medicine Medical University of South Carolina, 171 Ashley Ave, Room 812-CSB, Charleston, SC 29425-2220; e-mail: silvestri@musc.edu

*Values are given as the mean (range) or No. (%).

*Values are given as the mean (± SD) or No. (%).

†p < 0.001 (vs fospropofol, 2 mg/kg).

*Values are given as No. (%).

†p < 0.01 (vs fospropofol, 2 mg/kg).

‡Satisfaction scale ranged from 1 (dissatisfied) through 10 (highly satisfied).

§Comfort scale ranged from 1 (least comfortable) though 10 (most comfortable).

*Values are given as No. (%). Individual patients may be counted in more than one event category.

For editorial comment see page 4

This study was funded by a grant from MGI PHARMA, Inc (Bloomington, MN).

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


For editorial comment see page 4

For editorial comment see page 4

This study was funded by a grant from MGI PHARMA, Inc (Bloomington, MN).

This study was funded by a grant from MGI PHARMA, Inc (Bloomington, MN).

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2009;135(1):41-47. doi:10.1378/chest.08-0623
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Background:  Fospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated the use of fospropofol in patients undergoing flexible bronchoscopy.

Methods:  Patients ≥ 18 years of age were randomized (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl, 50 μg. Supplemental doses of each were given per protocol. The primary end point was sedation success, which was defined as follows: three consecutive Modified Observer's Assessment of Alertness/Sedation scores of ≤ 4 plus procedure completion without alternative sedative medication and/or mechanical ventilation. Other end points included treatment success, patient/physician satisfaction, and safety.

Results:  Of 252 patients, 150 were randomized to receive 6.5 mg/kg fospropofol; 102 were randomized to receive 2 mg/kg fospropofol. Sedation success rates were 88.7% and 27.5%, respectively (p < 0.0001). Treatment successes (91.3% vs 41.2%, respectively; p < 0.001), willingness to be treated again (94.6% vs 78.2%, respectively; p < 0.001), and absence of procedural recall (83.3% vs 55.4%, respectively; p < 0.001) were significantly better with the administration of 6.5 mg/kg fospropofol. The median time to full alertness was slightly longer for the 6.5 mg/kg dose (5.5 vs 3.0 min, respectively). The proportion of patients requiring supplemental therapy with analgesics (16.7% vs 37.3%, respectively) and the use of alternative sedative medications (8.0% vs 58.8%, respectively) were lower for patients in the 6.5 mg/kg dose group (all comparisons, p < 0.001). The most frequent adverse events (AEs) were transient and self-limited paresthesias and pruritus of mild-to-moderate severity. Hypoxemia (predominantly mild-to-moderate) was the most common sedation-related AE, and occurred in 15.4% and 12.6% of patients, respectively, in the 6.5 and 2 mg/kg fospropofol dose groups.

Conclusions:  Fospropofol provided safe and effective sedation for patients undergoing flexible bronchoscopy.

Trial registration:  Clinical Trials.gov Identifier: NCT00306722

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