Non-anesthesiologist administration of propofol sedation for colonoscopy is safe in low risk patients: results of a noninferiority randomized controlled trial

Background and study aims: Propofol provides the best sedation in colonoscopy. The safety of non-anesthesiologist administration of propofol (NAAP) is still a matter of debate. The aim of the current study was to evaluate sedation safety, colonoscopy quality, and patient satisfaction with NAAP.

Patients and methods: The study was a single-blinded, noninferiority, randomized controlled trial comparing NAAP (Group A) with anesthesiologist-administered sedation (Group B) performed at a single academic institution. Patients (18 – 80 years) who underwent colonoscopy and were at low anesthetic risk (American Society of Anesthesiologists class I – II) were included. The primary end point was the incidence of adverse events. Secondary end points were propofol dose, patient satisfaction and pain, colonoscopy quality indicators, and procedure and recovery times.

Results: A total of 277 patients were included in the analysis. The incidence of adverse events was 39.3 % in Group A and 39.0 % in Group B (absolute difference – 0.3 %, 95 % confidence interval [CI] – 12.0 % to 11.4 %; P = 0.959). There were no sentinel adverse events. The following interventions (Group A vs. Group B) were necessary: atropine administration (0 % vs. 5.5 %; P = 0.004); airway repositioning (8.7 % vs. 4.7 %; P = 0.196); increased oxygen administration (6.7 % vs. 3.9 %; P = 0.317), and increased fluid rate (2.7 % vs. 0.8 %; P = 0.379). There were no differences in cecal intubation and adenoma detection rates. Recovery times were longer in Group B (58 ± 33 vs. 67 ± 29 minutes; P = 0.032). There were no differences in mean propofol dose, withdrawal time, painless colonoscopy, satisfaction, and amnesia. All but two patients (Group B) were willing to repeat the colonoscopy.

Conclusions: NAAP is equivalent to anesthesiologist-administered sedation in the rate of adverse events in a low risk population.

Trial registration: ClinicalTrials.gov (NCT02067065).

• References

• 1 Ferlay J, Shin H, Bray F et al. GLOBOCAN 2008 v2.0, Cancer incidence and mortality worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer; 2010 Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
• 2 Qaseem A, Denberg TD, Hopkins Jr RH et al. Screening for colorectal cancer: a guidance statement from the American College of Physicians. Ann Intern Med 2012; 156: 378-386
• 3 Rex DK, Johnson DA, Anderson JC et al. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol 2009; 104: 739-750
• 4 Vargo JJ, DeLegge MH, Feld AD et al. Multisociety sedation curriculum for gastrointestinal endoscopy. Gastroenterology 2012; 143: e18-41
• 5 Dumonceau JM, Riphaus A, Aparicio JR et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy 2010; 42: 960-974
• 6 Dumonceau JM, Riphaus A, Beilenhoff U et al. European curriculum for sedation training in gastrointestinal endoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). Endoscopy 2013; 45: 496-504
• 7 Lichtenstein DR, Jagannath S, Baron TH et al. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc 2008; 68: 205-216
• 8 Rex DK, Deenadayalu VP, Eid E et al. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology 2009; 137: 1229-1237
• 9 Kazama T, Takeuchi K, Ikeda K et al. Optimal propofol plasma concentration during upper gastrointestinal endoscopy in young, middle-aged, and elderly patients. Anesthesiology 2000; 93: 662-669
• 10 Vargo JJ, Zuccaro Jr 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
• 11 Bannert C, Reinhart K, Dunkler D et al. Sedation in screening colonoscopy: impact on quality indicators and complications. Am J Gastroenterol 2012; 107: 1837-1848
• 12 Wang D, Chen C, Chen J et al. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One 2013; 8: e53311
• 13 McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc 2008; 67: 910-923
• 14 Singh H, Poluha W, Cheung M et al. Propofol for sedation during colonoscopy. Cochrane Database Syst Rev 2008; CD006268.pub2: CD006268
• 15 de Paulo GA, Martins FPB, Macedo EP et al. Sedation in gastrointestinal endoscopy: a prospective study comparing nonanesthesiologist-administered propofol and monitored anesthesia care. Endosc Int Open 2015; 03: E7-E13
• 16 Igea F, Casellas JA, Gonzalez-Huix F et al. Sedation for gastrointestinal endoscopy. Clinical practice guidelines of the Sociedad Espanola de Endoscopia Digestiva. Rev Esp Enferm Dig 2014; 106: 195-211
• 17 Dumonceau JM, Riphaus A, Aparicio JR et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol 2010; 27: 1016-1030
• 18 Riphaus A, Wehrmann T, Weber B et al. [S3-guidelines--sedation in gastrointestinal endoscopy]. Z Gastroenterol 2008; 46: 1298-1330
• 19 Vargo JJ, Cohen LB, Rex DK et al. Position statement: Nonanesthesiologist administration of propofol for GI endoscopy. Gastroenterology 2009; 137: 2161-2167
• 20 Riphaus A, Macias-Gomez C, Deviere J et al. Propofol, the preferred sedation for screening colonoscopy, is underused. Results of an international survey. Dig Liver Dis 2012; 44: 389-392
• 21 Faulx AL, Vela S, Das A et al. The changing landscape of practice patterns regarding unsedated endoscopy and propofol use: a national Web survey. Gastrointest Endosc 2005; 62: 9-15
• 22 Cohen LB, Wecsler JS, Gaetano JN et al. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol 2006; 101: 967-974
• 23 Paspatis GA, Manolaraki MM, Tribonias G et al. Endoscopic sedation in Greece: results from a nationwide survey for the Hellenic Foundation of gastroenterology and nutrition. Dig Liver Dis 2009; 41: 807-811
• 24 Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey. Z Gastroenterol 2010; 48: 392-397
• 25 Poincloux L, Laquiere A, Bazin JE et al. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liver Dis 2011; 43: 553-558
• 26 Ferreira AO, Torres J, Dinis-Ribeiro M et al. Endoscopic sedation and monitoring practices in Portugal: a nationwide web-based survey. Eur J Gastroenterol Hepatol 2015; 27: 265-270
• 27 Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth 1995; 7: 500-506
• 28 Mason KP, Green SM, Piacevoli Q. Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from the World SIVA International Sedation Task Force. Br J Anaesth 2012; 108: 13-20
• 29 Wang D, Wang S, Chen J et al. Propofol combined with traditional sedative agents versus propofol- alone sedation for gastrointestinal endoscopy: a meta-analysis. Scand J Gastroenterol 2013; 48: 101-110
• 30 Qadeer MA, Vargo JJ, Khandwala F et al. Propofol versus traditional sedative agents for gastrointestinal endoscopy: a meta-analysis. Clin Gastroenterol Hepatol 2005; 3: 1049-1056
• 31 Lucendo AJ, Gonzalez-Huix F, Tenias JM et al. Gastrointestinal endoscopy sedation and monitoring practices in Spain: a nationwide survey in the year 2014. Endoscopy 2015; 47: 383-390
• 32 Riphaus A, Geist F, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: re-evaluation from the first nationwide survey 3 years after the implementation of an evidence and consent based national guideline. Z Gastroenterol 2013; 51: 1082-1088
• 33 Heuss LT, Froehlich F, Beglinger C. Nonanesthesiologist-administered propofol sedation: from the exception to standard practice. Sedation and monitoring trends over 20 years. Endoscopy 2012; 44: 504-511
• 34 Schreiber F. Austrian Society of Gastroenterology and Hepatology (OGGH) – guidelines on sedation and monitoring during gastrointestinal endoscopy. Endoscopy 2007; 39: 259-262
• 35 Sieg A, Beck S, Scholl SG et al. Safety analysis of endoscopist-directed propofol sedation: a prospective, national multicenter study of 24 441 patients in German outpatient practices. J Gastroenterol Hepatol 2014; 29: 517-523
• 36 Perel A. Non-anaesthesiologists should not be allowed to administer propofol for procedural sedation: a consensus statement of 21 European national societies of anaesthesia. Eur J Anaesthesiol 2011; 28: 580-584