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Michael A. Jantz, MD, FCCP
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University of Florida Gainesville, FL

Correspondence to: Michael A. Jantz, MD, FCCP, University of Florida, Medicine/Pulmonary & Critical Care, 1600 SW Archer Rd, Box 100225, Gainesville, FL 32610-0225; e-mail: Michael.Jantz@medicine.ufl.edu


Dr. Jantz has 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/site/misc/reprints.xhtml).


© 2009 American College of Chest Physicians


Chest. 2009;136(3):945-946. doi:10.1378/chest.09-1170
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To the Editor:

I appreciate the comments in response to my editorial1 provided by Drs. McLarney, Hatton, and Swan regarding fospropofol and patient safety. All physicians, including pulmonary and critical care physicians performing bronchoscopy, should indeed be concerned with patient safety. I would agree with the statement that fospropofol can have significant respiratory and hemodynamic depression, which can be disastrous for the patient if not detected and treated aggressively. However, this is potentially true for all sedative medications used in the bronchoscopy suite.

I believe the available data suggest that fospropofol can be used safely for moderate sedation without anesthesia monitoring. In the study by Silvestri and colleagues2 involving 252 patients undergoing bronchoscopy, fospropofol combined with fentanyl was efficacious, with hypoxemia occurring in 14.3% of patients and hypotension in 3.2% of patients. Most patients responded to increased oxygen flow and stimulation. One patient required 100% oxygenation by facemask, and one patient required bag-valve mask ventilation; both were in the 6.5 mg/kg group. This is similar to other studies of sedation for bronchoscopy. In a study3 of 101 patients undergoing colonoscopy who received varying doses of fospropofol with 50 μg of fentanyl, two episodes of hypoxemia occurred, both in the 6.5 mg/kg group. Additional studies comparing fospropofol with sedation regimens typically used for bronchoscopy, such as midazolam plus fentanyl, should be performed to compare the efficacy and safety of fospropofol with those of currently used agents. These data, however, are unlikely to change the US Food and Drug Administration labeling for fospropofol. The use of propofol by gastroenterologists has been an area of controversy and political jousting in the past.4

I would agree with the US Food and Drug Administration labeling for fospropofol5 that “patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilities for providing cardiopulmonary resuscitation must be immediately available.” This should be, and I believe is, the standard of care for most bronchoscopy suites in the United States. Pulmonologists, in my opinion, are capable of managing the airway should the patient temporarily lapse into deep sedation or a state of general anesthesia and are capable of dealing with hypotension during bronchoscopic procedures. As such, I disagree with the labeling that fospropofol should be administered “only by persons trained in the administration of general anesthesia.” I believe fospropofol can be safely used by pulmonary and critical care physicians in the bronchoscopy suite.

Jantz MA. The old and the new of sedation for bronchoscopy. Chest. 2009;135:4-6. [PubMed] [CrossRef]
 
Silvestri GA, Vincent BD, Wahidi MM, et al. 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;135:41-47. [PubMed]
 
Cohen LB. Clinical trial: a dose-response study of fospropofol disodium for moderate sedation during colonoscopy. Aliment Pharmacol Ther. 2008;27:597-608. [PubMed]
 
Rex DK. The science and politics of propofol. Am J Gastroenterol. 2004;99:2080-2083. [PubMed]
 
US Food and Drug Administration Highlights of prescribing information: Lusedra.Accessed July 26, 2009 Available at:http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022244lbl.pdf.
 

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References

Jantz MA. The old and the new of sedation for bronchoscopy. Chest. 2009;135:4-6. [PubMed] [CrossRef]
 
Silvestri GA, Vincent BD, Wahidi MM, et al. 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;135:41-47. [PubMed]
 
Cohen LB. Clinical trial: a dose-response study of fospropofol disodium for moderate sedation during colonoscopy. Aliment Pharmacol Ther. 2008;27:597-608. [PubMed]
 
Rex DK. The science and politics of propofol. Am J Gastroenterol. 2004;99:2080-2083. [PubMed]
 
US Food and Drug Administration Highlights of prescribing information: Lusedra.Accessed July 26, 2009 Available at:http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022244lbl.pdf.
 
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