Fospropofol: A new sedative-hypnotic agent for monitored anesthesia care

Annals of Pharmacotherapy

Volumn 43, Issue 11, 2009, Pages 1802-1808

  Moore, Gina D ^a   Walker, Alyssa M ^b   MacLaren, Robert ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b Exempla Lutheran Medical Center   (United States)

Author keywords

Bronchoscopy; Colonoscopy; Formulary; Fospropofol; Monitored anesthesia care; Sedation

Indexed keywords

BENZODIAZEPINE; FENTANYL; FOSPROPOFOL; HYPNOTIC SEDATIVE AGENT; LUSEDRA; MIDAZOLAM; PETHIDINE; PROPOFOL; UNCLASSIFIED DRUG;

BACTERIUM CONTAMINATION; BLOOD PRESSURE MONITORING; BRONCHOSCOPY; CLINICAL TRIAL; COLONOSCOPY; CONSCIOUSNESS; DEEP SEDATION; DRUG COST; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INFORMATION; DRUG SAFETY; ELECTROCARDIOGRAM; EMBASE; FAT INTAKE; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERTRIGLYCERIDEMIA; HYPOTENSION; HYPOXEMIA; INFECTION; INJECTION SITE PAIN; INTERMETHOD COMPARISON; MEDLINE; META ANALYSIS; MONITORED ANESTHESIA CARE; MONITORING; PHARMACODYNAMICS; PRIORITY JOURNAL; PUBLICATION; PULSE OXIMETRY; REVIEW; RISK ASSESSMENT; SEDATION; SOLUBILITY; SYSTEMATIC REVIEW; TRANQUILIZING ACTIVITY;

ANESTHESIA; CLINICAL TRIALS AS TOPIC; DRUG MONITORING; HUMANS; HYPNOTICS AND SEDATIVES; PROPOFOL;

EID: 70449707741     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1M290     Document Type: Review

References (33)

1. Package insert. Lusedra (fospropofol disodium) injection. Research Triangle Park, NC: Eisai Corp., December 12, 2008.
2. Levitzky BE, Vargo JJ. Fospropofol disodium injection for the sedation of patients undergoing colonoscopy. Ther Clin Risk Manag 2008:4:733-738
3. Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol 2008;182: 227-252
4. Wang H, Cork R, Rao A. Development of a new generation of propofol. Curr Opin Anaesthesiol 2007;20:311-315
5. American Society of Anesthesiologists. Position on monitored anesthesia care. www.asahq.org/publicationsAndServices/standards/23.pdf (accessed 2009 Jun 18).
6. Miller RD. Ambulatory (outpatient) anesthesia. In: Fleisher LA, Johns RA, Savarese JJ, Wiener-Kronish JP, Young WL, eds. Miller's anesthesia. 6th ed. Philadelphia: Elsevier, 2005.
7. Bahn EL, Holt KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin North Am 2005;23:503-507
8. Lubarsky DA, Candiotti K, Harris E. Understanding modes of moderate sedation during gastrointestinal procedures: a current review of the literature. J Clin Anesth 2007;19:397-404. (Pubitemid 47380323)
9. Aisenberg J, Brill JV, Ladabaum U, Cohen LB. Sedation for gastrointestinal endoscopy: new practices, new economics. Am J Gastroenterol 2005;100:996-1000. (Pubitemid 40769032)
10. Aisenberg J, Cohen LB, Piorkowski JD. Propofol use under the direction of trained gastroenterologists: an analysis of the medicolegal implications. Am J Gastroenterol 2007;101:707-713 (Pubitemid 46496642)
11. Luginbuhl M, Vuilleumier P, Schumacher P, Stuber F. Anesthesia or sedation for gastroenterologic endoscopies. Curr Opin Anesthesiol 2009; 22:524-531
12. Anesthetists for the safe administration of propofol, 2009. http://safepropofol. org/ (accessed 2009 May 13).
13. ISMP Safety Alert November 3, 2005: Propofol sedation: who should administer? http://safepropofol.org/ (accessed 2009 May 13).
14. American Society of Anesthesiologists Task Force on Sedatin and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-1017
15. Ensuring competence in endoscopy, executive briefing. ASGE taskforce on ensuring competence in endoscopy and American College of Gastroenterology executive and practice management committees. www.acg.gi. org/physicians/pdfs/ ExecutiveBriefing.pdf (accessed 2009 May 13).
16. Sipe BW, Rex DK, Latinovich D, et al. Propofol versus midazolam/ meperidine for outpatient colonoscopy: administration by nurses supervised by endoscopists. Gastrointest Endosc 2002;55:815-825 (Pubitemid 41127896)
17. Rex DK, Deenadayalu VP, Eid E, et al. Endoscopist directed administration of propofol: a world-wide safety experience. Gastroenterology (in press).
18. Gan TJ. Pharmacokinetic and pharmacodynamic characteristics of medications used for moderate sedation. Clin Pharmacokinet 2006;45:855-869
19. Fechner J, Schwilden H, Schuttler J. Pharmacokinetics and pharmacodynamics of GPI 15715 or fospropofol (Aquavan injection) - a water-soluble propofol prodrug. Handb Exp Pharmacol 2008;182:253-265
20. Fechner J, Ihmsen H, Hatterscheid D, et al. Pharmacokinetics and clinical pharmacodynamics of the new propofol prodrug GPI 15715 in volunteers. Anesthesiology 2003;99:303-313 (Pubitemid 36909556)
21. Gibiansky E, Struys MM, Gibiansky L, et al. Aquavan injection, a watersoluble prodrug of propofol, as a bolus injection: a phase I dose-escalation comparison with Diprivan (part 1): pharmacokinetics. Anesthesiology 2005;102:718-729 (Pubitemid 41415520)
22. Fechner J, Ihmsen H, Hatterscheid D, et al. Comparative pharmacokinetics and pharmacodynamics of the new propofol prodrug GPI 15715 and propofol emulsion. Anesthesiology 2004;101:626-639 (Pubitemid 39121642)
23. d'Alessandro A, Osterloh JD, Chuwers P, Quinln PJ, Kelly TJ, Becker CE. Formate in serum and urine after controlled methanol exposure at the threshold limit value. Environ Health Perspect 1994;102:178-181
24. Oda Y, Hamaoka N, Hiroi T, et al. Involvement of human liver cytochrome P4502B6 in the metabolism of propofol. Br J Clin Pharmacol 2001;51:281-285 (Pubitemid 32391505)
25. Struys MM, Vanluchene AL, Gibiansky E, et al. Aquavan injection, a water-soluble prodrug of propofol, as a bolus injection: a phase I doseescalation comparison with Diprivan (part 2): pharmacodynamics and safety. Anesthesiology 2005;103:730-743 (Pubitemid 41415521)
26. Yavas S, Lizdas D, Gravenstein N, Lampotang S. Interactive web simulation for propofol and fospropofol, a new propofol prodrug. Anes Analg 2008;106:880-883 (Pubitemid 351301410)
27. Shah A, Mistry B, Gibiansky E, Gibiansky L. Fospropofol assay: issues and impact on pharmacokinetic and pharmacodynamic evaluation. Eur J Anaesthesiol 2009;26:81.
28. Comparison of Aquavan injection to Diprivan injectable emulsion for anesthesia during coronary artery surgery. http://clinicaltrials.gov (accessed 2009 May 14).
29. Cohen LB. Clinical trial: a dose-response study of fospropofol disodium for moderate sedation during colonoscopy. Aliment Pharmacol Ther 2008;27:597-608.
30. Rex DK, Cohen LB, Kline J. Fospropofol disodium is effective and safe for minimal to moderate sedation in patients undergoing colonoscopy: results of a phase 3, randomized, double-blind, trial (abstract W1451). Gastrointest Endosc 2007;65(5):AB369. Poster presented at: Digestive Disease Week Annual Meeting, May 19-24, 2007, Washington, DC.
31. Vargo JJ, Bramely T, Meyer K, Nightengale B. Practice efficiency and economics - the case for rapid recovery sedation agents for colonoscopy in a screening population. J Clin Gastroenterol 2007;41:591-598 (Pubitemid 46956517)
32. Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. 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
33. Kam PCA, Cardone D. Propofol infusion syndrome. Anesthesia 2007; 62:690-701.