Sedation-Associated Complications in Endoscopy – Prospective Multicentre Survey of 191142 Patients

Abstract

Background/Aims: Propofol sedation is applied as moderate sedation for almost all diagnostic and interventional endoscopies. Propofol sedation bears the risk of complications such as respiratory as well as cardiopulmonary insufficiency including sedation-induced death. According to recent guidelines, non-anesthesiologist-administered propofol (NAAP) should be performed by an additional person who has NAAP as their sole task.

Methods: In a prospective multicentre survey involving 191,142 patients, clinically relevant endoscopy-associated complications were registered from 02/2010 to 01/2012.

Results: The majority of propofol sedations were applied without additional persons for NAAP. Overall endoscopy-related complication rate was 0.0022 % (n = 424) and sedation-related complications 0.00 042 % (n = 82). Variability over time and between the clinics was low and not influenced by the number of endoscopies performed during the investigation period. Sedation-related death occurred in 6 patients (0.00 003 %), 50 % during emergency endoscopies. In all sedation-associated deaths the patients had ASA class 3 before endoscopy. All fatal complications occurred in the presence of an additional trained person for NAAP.

Conclusion: This large prospective survey shows that propofol sedation in gastrointestinal endoscopy is a safe procedure with a low potential of risk in daily routine. However, high risk patients (ASA ≥ 3) should be identified, especially before emergency endoscopies and managed by additional persons for NAAP and under intensive care surveillance.

Zusammenfassung

Hintergrund/Ziele: Die Propofol-Sedierung wird als moderate Sedierung für die Mehrzahl der diagnostischen und interventionellen Endoskopien verwendet. Die Propofol-Sedierung birgt das Risiko einer respiratorischen bzw. kardiopulmonalen Insuffizienz mit sedierungsinduziertem Tod. Gemäß den aktuellen Leitlinien wird daher für die Propofol-Sedierung eine zusätzliche Person gefordert, die ausschließlich für die Überwachung der Patienten zuständig ist (NAAP).

Methoden: In einer prospektiven multizentrischen Dokumentation wurden von 02/2010 – 01/2012 sedierungsassoziierte Komplikationen bei 191 142 Patienten systematisch erfasst.

Ergebnisse: Die Mehrzahl der Propofol-Sedierungen wurde ohne zusätzliche Person für NAAP durchgeführt. Die gesamten Endoskopie- bzw. die sedierungsassoziierten Komplikationsraten waren 0,0022 % (n = 424) bzw. 0,00 042 % (n = 82). Die Variabilität im Zeitverlauf und zwischen den beteiligten Kliniken war niedrig und nicht von der Anzahl der Endoskopien beeinflusst. Sedierungsassoziierte Todesfälle traten bei 6 Patienten (0,00 003 %) auf, in 50 % während Notfallendoskopien. Alle verstorbenen Patienten zeigten einen deutlich reduzierten Zustand mit ASA 3 vor Endoskopie. Die Endoskopie bei allen Todesfällen wurde in Anwesenheit einer zusätzlichen Person für NAAP durchgeführt.

Schlussfolgerung: Diese große prospektive Erfassung zeigt, dass die Propofol-Sedierung im klinischen Alltag sicher ist und nur ein geringes Risiko aufweist. Allerdings sollten Patienten mit hohem Risiko (ASA ≥ 3), insbesondere vor Notfallendoskopien, identifiziert und durch eine zusätzliche Person für NAAP unter Intensivbedingungen betreut werden.

Schlüsselwörter

Endoskopie - Sedierung - Komplikationen

Key words

endoscopy - sedation - complications

• References

• 1 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
• 2 Riphaus A, Rabofski M, Wehrmann T. Sedierung in der gastrointestinalen Endoskopie in Deutschland. Z Gastroenterol 2010; 48: 392-397
• 3 Jung M, Hofmann C, Kiesslich R et al. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam. Endoscopy 2000; 32: 233-238
• 4 Meining A, Semmler V, Kassem AM et al. The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam. Endoscopy 2007; 39: 345-349
• 5 Heuss LT, Froehlich F, Beglinger C. Changing patterns of sedation and monitoring practice during endoscopy: results of a nationwide survey in Switzerland. Endoscopy 2005; 37: 161-166
• 6 Rex D, Deenadayalu V, Eid E et al. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology 2009; 137: 1229-1237
• 7 Paspatis G, Manolaraki M, Tribonias G et al. Endoscopic sedation in Greece: results from a nationwide survey for the Hellenic Foundation of gastroenterology and nutrition. Dig Liv Dis 2009; 41: 807-811
• 8 Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey. Zeitschrift für Gastroenterologie 2010; 48: 392-397
• 9 Arrowsmith JB, Gerstman BB, Fleischer DE et al. Results from the American Society for Gastrointestinal Endoscopy/U. S. Food and Drug Administration collaborative study on complication rates and drug use during gastrointestinal endoscopy. Gastrointest Endosc 1991; 37 (04) 421-427
• 10 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
• 11 Singh H, Poluha W, Cheung M et al. Propofol for sedation during colonoscopy. Cochrane database of systematic reviews 2008; CD006268
• 12 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
• 13 Paspatis GA, Manolaraki MM, Vardas E et al. Deep sedation for endoscopic retrograde cholangiopancreatography: intravenous propofol alone versus intravenous propofol with oral midazolam premedication. Endoscopy 2008; 40: 308-313
• 14 Ong WC, Santosh D, Lakhtakia S et al. A randomized controlled trial on use of propofol alone versus propofol with midazolam, ketamine, and pentazocine “sedato-analgesic cocktail” for sedation during ERCP. Endoscopy 2007; 39: 807-812
• 15 Disma N, Astuto M, Rizzo G et al. Propofol sedation with fentanyl or midazolam during oesophagogastroduodenoscopy in children. Eur J Anaesth 2005; 22: 848-852
• 16 Paspatis GA, Charoniti I, Manolaraki M et al. Synergistic sedation with oral midazolam as a premedication and intravenous propofol versus intravenous propofol alone in upper gastrointestinal endoscopies in children: a prospective, randomized study. J Pediatr Gastroenterol Nutr 2006; 43: 195-199
• 17 Padmanabhan U, Leslie K, Eer AS et al. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg 2009; 109: 1448-1455
• 18 VanNatta ME, Rex DK. Propofol alone titrated to deep sedation versus propofol in combination with opioids and/or benzodiazepines and titrated to moderate sedation for colonoscopy. Am J Gastroenterol 2006; 101: 2209-2217
• 19 Riphaus A, Wehrmann T, Weber B et al. S3 Guideline: Sedation for gastrointestinal endoscopy 2008. Endoscopy 2009; 41: 787-815
• 20 Lichtenstein DR, Jagannath S, Baron TH et al. Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc 2008; 68: 815-826
• 21 Dumonceau JM, Riphaus A, Aparicio JR et al. Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy 2010; 42: 960-974
• 22 Cohen LB, Dubovsky AN, Aisenberg J et al. Propofol for endoscopic sedation: a protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc 2003; 58: 725-732
• 23 Külling D, Orlandi M, Inauen W. Propofol sedation during endoscopic procedures: howmuch staff and monitoring are necessary?. Gastrointest Endosc 2007; 66: 443-449
• 24 Yusoff IF, Raymond G, Sahai AV. Endoscopist administered propofol for upper-GI EUS is safe and effective: a prospective study in 500 patients. Gastrointest Endosc 2004; 60: 356-360
• 25 Behrens A, Labenz J, Schuler A et al. How safe is sedation in gastrointestinal endoscopy? A multicenter analysis of 388.404 endoscopies. An analysis of data from prospective registries of complications managed by members of the working group of leading hospital gastroenterologists (ALGK). UEGW 2012; (submitted)
• 26 Behrens A, Kainzinger FA, Nölling T et al. S3 guideline on „sedation in gastrointetsinal endoscopy“, how much does the new guideline cost in everyday hospital work? A calculation model and analysis of implementation in 2011 among ALGK members. Z Gastroenterol 2012; 50: 1002-1007
• 27 Sharma VK, Nguyen CC, Crowell MD et al. A national study of cardiopulmonary unplanned events after GI endoscopy. Gastrointest Endosc 2007; 6: 27-34