Chest
Original ResearchInterventional PulmonologyA Phase 3, Randomized, Double-Blind Study To Assess the Efficacy and Safety of Fospropofol Disodium Injection for Moderate Sedation in Patients Undergoing Flexible Bronchoscopy
Section snippets
Study Design
This was a phase 3, randomized, double-blind, dose-controlled study. The institutional review board at each study site approved the protocol. All patients provided oral and written informed consent.22
Patients
Patients ≥ 18 years of age and with an American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4 were eligible for study enrollment. Female patients of child-bearing age had to have a negative pregnancy test result and to have used an acceptable method of birth
Patients
Twenty-four centers screened 290 patients, and 256 patients were randomized (Fig 1). Centers enrolled between 1 and 35 patients (mean, 11 patients). Four patients were eliminated from the study prior to drug administration due to abnormal laboratory test results, pharmacy delays, invalid consent, or bronchoscopy cancellation (each category, n = 1). Thus, 252 patients were included in the modified intent-to-treat population. Demographic and baseline characteristics were similar between the
Discussion
Most guidelines in the United States8, 29 and Europe30 recommend the sedation of patients when undergoing bronchoscopy. An ideal sedative should be easy to use and have a rapid onset, short duration, and quick recovery with a rapid return of cognition, as well as a predictable pharmacokinetic/pharmacodynamic profile. The most commonly used agents (benzodiazepines and opioids) have some of these properties, but each has limitations. Fospropofol may have certain advantages when compared to lipid
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Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy
2019, ChestCitation Excerpt :Guidelines6,23 recommend sedation for patients undergoing bronchoscopy. The ideal sedative should be easy to use and have a rapid onset, short duration, and quick recovery with rapid return of cognition, as well as a predictable pharmacokinetic/pharmacodynamic and safety profile.24 Benzodiazepines and opioids have some of these properties, but with limitations such as prolonged sedation and increased hospital length of stay in select populations.17
New Hypnotic Drug Development and Pharmacologic Considerations for Clinical Anesthesia
2017, Anesthesiology Clinics
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).