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Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications
  1. Angelika Behrens1,
  2. Anton Kreuzmayr2,
  3. Hendrik Manner3,
  4. Herbert Koop4,
  5. Albrecht Lorenz4,
  6. Claus Schaefer5,
  7. Mathais Plauth6,
  8. Jens-Uwe Jetschmann6,
  9. Christian von Tirpitz7,
  10. Marcus Ewald8,
  11. Michael Sackmann9,
  12. Wanja Renner9,
  13. Martin Krüger10,
  14. Dieter Schwab11,
  15. Werner Hoffmann12,
  16. Olaf Engelke12,
  17. Oliver Pech13,
  18. Frank Kullmann14,
  19. Sonja Pampuch14,
  20. Berthold Lenfers15,
  21. Uwe Weickert16,
  22. Dieter Schilling17,
  23. Stephan Boehm18,
  24. Susanne Beckebaum18,
  25. Vito Cicinnati18,
  26. Joachim F Erckenbrecht19,
  27. Franz Ludwig Dumoulin20,
  28. Claus Benz21,
  29. Thomas Rabenstein22,
  30. Georg Haltern23,
  31. Martin Balsliemke23,
  32. Christian de Mas24,
  33. Gerhard Kleber25,
  34. Christian Pehl26,
  35. Christoph Vogt27,
  36. Ralf Kiesslich28,
  37. Wolfgang Fischbach29,
  38. Irmtraut Koop30,
  39. Jens Kuehne31,
  40. Matthias Breidert32,
  41. Nils Lennart Sass33,
  42. Andrea May34,
  43. Christian Friedrich34,
  44. Ronni Veitt35,
  45. Rainer Porschen36,
  46. Mark Ellrichmann37,
  47. Alexander Arlt37,
  48. Wolfgang Schmitt38,
  49. Markus Dollhopf38,
  50. Werner Schmidbaur39,
  51. Axel Dignass40,
  52. Volker Schmitz41,
  53. J Labenz42,
  54. Gernot Kaiser43,
  55. Alexander Krannich44,
  56. Nico Barteska45,
  57. Christian Ell34
  1. 1 Department of Internal Medicine and Gastroenterology, Evangelische Elisabeth Klinik, Teaching Hospital, Charité University Medicine, Berlin, Germany
  2. 2 Klinik für Innere Medizin und Gastroenterologie, Klinikum Traunstein, Essen, Germany
  3. 3 Klinik für Innere Medizin und Gastroenterologie, Dr. Horst-Schmidt-Kliniken, Wiesbaden, Germany
  4. 4 Klinik für Allgemeine Innere Medizin und Gastroenterologie, Helios Klinikum Berlin-Buch, Berlin, Germany
  5. 5 Medizinische Klinik II, Klinikum Neumarkt, Neumarkt, Germany
  6. 6 Klinik für Innere Medizin, Gastroenterologie, Klinikum Dessau, Dessau, Germany
  7. 7 Medizinische Klinik, Sana Kliniken Landkreis Biberach, Biberach, Germany
  8. 8 Medizinische Klinik — Schwerpunkt Gastroenterologie, Onkologie, Klinikum Kulmbach, Kulmbach, Germany
  9. 9 Medizinische Klinik II, Klinikum Bamberg, Bamberg, Germany
  10. 10 Klinik für Innere Medizin und Gastroenterologie, Ev. Krankehaus Bielefeld, Bielefeld, Germany
  11. 11 Medizinische Klinik II, Krankenhaus Martha-Maria Nürnberg, Nuremberg, Germany
  12. 12 Medizinische Klinik II, St. Anna Hospital, Herne, Germany
  13. 13 Klinik für Innere Medizin und interventionelle Gastroenterologie, Krankenhaus Barmherzige Brüder, Regensburg, Germany
  14. 14 Medizinische Klinik I, Klinikum Weiden, Weiden, Germany
  15. 15 Klinik für Gastroeterologie, St. Marien Hospital Klinikum Lünen, Luenen, Germany
  16. 16 Medizinische Klinik II, SLK Kliniken Heilbronn, Heilbronn, Germany
  17. 17 Medizinische Klinik II, Diakonissenkrankenhaus Mannheim, Mannheim, Germany
  18. 18 Medizinische Klinik für Innere Medizin, Gastroenterologie und Hepatologie, Katholische Kliniken Ruhrhalbinsel, Essen, Germany
  19. 19 Klinik für Innere Medizin mit Gastroenterologie und Onkologie, Florence-Nightingale-Krankenhaus, Düsseldorf, Germany
  20. 20 Allgemeine Innere Medizin, Gastroenterologie und Diabetologie, Gemeinschaftskrankenhaus Bonn, Bonn, Germany
  21. 21 Innere Medizin, Evangelisches Krankenhaus Köln-Weyertal, Cologne, Germany
  22. 22 Klinik für Innere Medizin, Diakonissen-Stiftungs-Krankenhaus Speyer, Speyer, Germany
  23. 23 Gastroenterologie, Kreiskrankenhaus Dormagen, Dormagen, Germany
  24. 24 Klinik für Innere Medizin - Gastroenterologie, Marienhaus St.Elisabeth Neuwied, Neuwied, Germany
  25. 25 Innere Medizin I, Ostalb Klinikum, Aalen, Germany
  26. 26 Innere Medizin, Krankenhaus Vilsbiburg, Vilsbiburg, Germany
  27. 27 Innere Medizin, St. Josef Krankenhaus Moers, Moers, Germany
  28. 28 Innere Medizin, St. Marienkrankenhaus, Frankfurt, Germany
  29. 29 Medizinische Klinik II, Klinikum Aschaffenburg, Aschaffenburg, Germany
  30. 30 Allgemeine Innere Medizin und Gastroenterologie, Ev. Amalie Sieveking-Krankenhaus, Hamburg, Germany
  31. 31 Klinik für Innere Medizin, Pius-Hospital, Oldenburg, Germany
  32. 32 Gastroenterologie und Infektiologie, Klinik Koesching, Koesching, Germany
  33. 33 Innere Medizin, Klinik Husum, Husum, Germany
  34. 34 Medizinische Klinik II, Sana Klinikum Offenbach, Offenbach, Germany
  35. 35 Klinik für Innere Medizin I - Gastroenterologie, internistische Onkologie, Elisabeth Klinikum Schmalkalden, Schmalkalden, Germany
  36. 36 Klinik für Innere Medizin, Klinikum Bremen-Ost, Bremen, Germany
  37. 37 Klinik für Innere Medizin 1, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
  38. 38 Klinik für Gastroenterologie und Hepatologie, Klinikum Neuperlach, Munich, Germany
  39. 39 Klinik für Gastroenterologie und Hepatologie, Stiftungsklinik Weissenhorn, Weissenhorn, Germany
  40. 40 Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt, Germany
  41. 41 Innere Medizin, Krankenhaus St. Marienwörth, Bad Kreuznach, Germany
  42. 42 Innere Medizin, Ev.-Jung-Stilling-KKH, Siegen, Germany
  43. 43 FB Wirtschafts- und Sozialwissenschaften, Hochschule Nordhausen, Nordhausen, Germany
  44. 44 Koordinierungszentrum Klinische Studien, Charité - Universitätsmedizin Berlin, Berlin, Germany
  45. 45 Klinik für Gastroenterologie, Vivantes Klinikum im Friedrichshain, Teaching hospital, Charité University Medicine, Berlin, Germany
  1. Correspondence to Dr Angelika Behrens, Department of Internal Medicine and Gastroenterology, Evangelische Elisabeth Klinik, Teaching hospital, Charité University Medicine, Berlin 10785, Germany; angelika.behrens{at}


Objectives Sedation has been established for GI endoscopic procedures in most countries, but it is also associated with an added risk of complications. Reported complication rates are variable due to different study methodologies and often limited sample size.

Designs Acute sedation-associated complications were prospectively recorded in an electronic endoscopy documentation in 39 study centres between December 2011 and August 2014 (median inclusion period 24 months). The sedation regimen was decided by each study centre.

Results A total of 368 206 endoscopies was recorded; 11% without sedation. Propofol was the dominant drug used (62% only, 22.5% in combination with midazolam). Of the sedated patients, 38 (0.01%) suffered a major complication, and overall mortality was 0.005% (n=15); minor complications occurred in 0.3%. Multivariate analysis showed the following independent risk factors for all complications: American Society of Anesthesiologists class >2 (OR 2.29) and type and duration of endoscopy. Of the sedation regimens, propofol monosedation had the lowest rate (OR 0.75) compared with midazolam (reference) and combinations (OR 1.0–1.5). Compared with primary care hospitals, tertiary referral centres had higher complication rates (OR 1.61). Notably, compared with sedation by a two-person endoscopy team (endoscopist/assistant; 53.5% of all procedures), adding another person for sedation (nurse, physician) was associated with higher complication rates (ORs 1.40–4.46), probably due to higher complexity of procedures not evident in the multivariate analysis.

Conclusions This large multicentre registry study confirmed that severe acute sedation-related complications are rare during GI endoscopy with a very low mortality. The data are useful for planning risk factor-adapted sedation management to further prevent sedation-associated complications in selected patients.

Trial registration number DRKS00007768; Pre-results.

  • cardiovascular complications
  • gastrointesinal endoscopy

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  • Contributors AB planned the study, did the study organisation, was involved in data collection, prepared the manuscript, was involved in thestatistical analysis and submitted the study. CE planned the study, was involved in data collection and study organisation, prepared the manuscript and was involved in the statistical analysis. WR, CF, SP and AA were involved indata collection. AK, HM, HK, CS, AL, MP, J-UJ, CvT, ME, MS, MK, DS, WH, OE, OP, FK, BL, UW, DS, SB, SuB, VC, JFE, FLD, CB, TR, GH, MB, CRdM, GK, CP, CV, RK, WF, IK, JK, MB, NLS, AM, RV, RP, ME, WS, MD, WSch, AD and VS were involved in data collection and in manuscript creation. JL was involved in manuscript creation. GK and AK were involved in the statistical analysis. NB was involved in creating figures.

  • Competing interests None declared.

  • Ethics approval Ethics Committee of the Medical Council of the state of Hesse (FF 8/2012) on 13 April 2011.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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