FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back



2005P-0267
CP 1
Volume 1

Citizen Petition

Tab 1 - 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. Published Material

Tab 2 - Koshy G, Nair S, Norkus EP, Hertan HI, Pitchumoni CS. Projpofol versus midazolam and meperidine for conscious sedation in GI endoscopy. Am J Gastroenterol. 2000; 95: 1476-1479. Published Material

Tab 3 - Ulmer BJ, Hansen JJ, Overley CA et al. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003; 1: 425-432. Published Material

Tab 4 - Graber RG. Propofol in the endoscopy suite: an anesthesiologist’s perspective. Gastrointest Endosc. 1999; 49: 803-806. Published Material

Tab 5 - Guise PA. Asystole following propofol and fentanyi in an anxious patrent. Anaesth Intensive Care. 1991; 19: 116-118. Published Material

Tab 6 - Carlsson U, Grattidge P. Sedation for upper gastrointestinal endoscopy: a comparative study of propofol and midazolam. Endoscopy. 1995; 27: 240-243. Published Material

Tab 7 - Chen SC, Rex DK. Review article: registered nurse-administered propofol sedation for endoscopy. Aliment Pharmacol Ther. 2004; 19: 147-155. Published Material

Tab 8 - Qadeer MA, Vargo JJ, Khandwala F, Zuccaro G. Propofol’s safety profile is equivalent to standard sedation with narcotics/benzodiazepines - a meta analysis [abstract]. Gastroenterology. 2005; 128: A-288. Published Material

Tab 9 - Qadeer MA, Vargo JJ, Khandwala F, Zuccaro G. Procedure-specific risk of cardiopulmonary complications is same for propofol and traditional sedation: a meta analysis [abstract]. Gastroenterology. 2005; 128: A-287. Published Material

Tab 10 - Gangi S, Saidi F, Patel K, Johnstone B, Jaeger J, Shine D. Cardiovascular complications after GI endoscopy: occurrence and risks in a large hospital system. Gastrointest Endosc. 2004; 60: 679-685. Published Material

Tab 11 - Cohen LB, Dubovsky AN, Aisenberg J, Miller KN. Propofol for endoscopic sedation: a protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc. 2003; 58: 325-732. Published Material

Tab 12 - Meltzer B. RNs pushing propofol. Outpatient Surg. 2003; 4: 24-37. Published Material

Tab 13 - Aisenberg J, Brill JV, Ladabaum U, Cohen LB. Sedation for gastrointestinal endoscopy: new practices, new economics. Am J Gastroenterol. 2005; 100: 996-1000. Published Material

Tab 14 - Bell GD, Charlton JE. Colonoscopy - is sedation necessary and is there any role for intravenous propofol? Endoscopy. 2000; 32: 264-267. Published Material

Tab 15 - Debate: propofol may be safely administered by trained nonanesthesiologists. Am J Gastroenterol. 2004; 99: 1207- 1211. Published Material

Tab 16 - Vargo JJ, Eisen GM, Faigel DO. Holub J, Lieberman DA. Anesthesiologist or non-anesthesiologist-administered propofol and cardiopulmonary complications for endoscopy: which is safer‘? [abstract]. Gastrointest Endosc. 2004; 59: AB93. Published Material

Tab 17 - Vargo JJ, Zuccaro G, Dumot JA et al. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002; 123: 8-16. Published Material

Tab 18 - Kongkam P, Pornphisarn B, Rerknimitr R. Non-anesthetist administered propofol for ERCP; efficacy, safety profile and side effect: a prospective randomized trial [abstract]. Gastrointest Endosc. 2004; 59: AB127. Published Material

Tab 19 - Vargo JJ, Eisen GM, Faigel DO, Holub J, Lieberman DA. Cardiopulmonary complications with non-anesthesiologist-administered propofol vs. standard sedation: the CORI experience [abstract]. Gnstrointest Endow. 2004; 59: AB132. Published Material

Tab 20 - Walker JA, McIntyre RD, Schleinitz PF et al. Nurse-administered propofol sedation without anesthesia specialists in 9152 endoscopic cases in an ambulatory surgery center. Am J Gastroenterol. 2003; 98: 1744-1750. Published Material

Tab 21 - Rex DK, Overley C, Kinser K et al. Safety of propofol administered by registered nurses with gastroenterologist supervision in 2000 endoscopic cases. Am J Gastroenterol. 2002; 97: 1159-1163. Published Material

Tab 22 - Rex DK, Heuss LT, Walker JA. Nurse administered propofol sedation: safety record among individual nurses and physicians in 3 centers [abstract]. Am J Gastroenterol. 2004; 99: S300. Published Material

Tab 23 - Tohda G, Higashi S, Sakumoto H, Sumiyoshi K, Kane T. Propofol sedation during endoscopic procedures: safety and effective administration by registered nurses, supervised by endoscopists [abstract]. Gastrointest Endosc. 2005; 61: AB123. Published Material

Tab 24 - Baptista A, Bonilla Y, Bronstein M et al. Propofol sedation for gastrointestinal endoscopy administered by nursing staff under gastroenterologist supervision [abstract]. Gastroimesr Endosc. 2005; 61: AB108. Published Material

Tab 25 - Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Risk stratification and safe administration of prbpofol by registered nurses supervised by the gastroenterologist: a prospective observational study of more than 2000 cases. Gastrointesr Endosc. 2003; 57: 664-671. Published Material

Tab 26 - Yusoff I, Raymond G, Sahai AV. Endoscopist administered propofol for upper-G1 EUS is safe and effective: a prospective study in 500 patients. Gasrrointest Endosc. 2004; 60: 356-360. Published Material

Tab 27 - Heuss LT. Schnieper P, Pflimlin E, Beglinger C. Nurse-administered sedation with propofol under observation of the endoscopist: a prospective observation study with more than 5000 patients [abstract]. Gastrointest Endosc, 2003; 57: AB105. Published Material

Tab 28 - Kulling D, Rothenbuhler R, Inauen W. Safety of nonanesthetist sedation with propofol for outpatient colonoscopy and esophagogastroduodenoscopy. Endoscopy. 2003; 35: 679-682. Published Material

Tab 29 - Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gasrroi~zresr Endosc. 2004; 59: 795-803. Published Material

Tab 30 - Heuss LT, Schnieper P, Drewe J, Pfl imlin E, Beglinger C.- Safety of propofol for conscious sedation during endoscopic procedures in high-risk patients-a prospective, controlled study. Am J Gasrroenrero1. 2003; 98: 1751-1757. Published Material

Tab 31 - Heuss LT, Schnieper P, Drewe J, Pflimlin E, Beglinger C. Conscious sedation with propofol in elderly batients: a prospective evaluation. Aliment Pharrnacol Tiler. 2003; 17: 1493-1501. Published Material


Top | Back

Page last updated July 12, 2005 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management