Safety of endoscopist-guided sedation in a low-risk collective
Authors: Behrens Angelika , Ell Christian ,   Studiengruppe ALGK-ProSed,   ALGK Study Group (Working Group of Senior Gastroenterological Hospital Physicians),   Prof. Thomas Frieling, chair of the Board of the Hospital Gastroenterology Consultants working group (ALGK),   Prof. Dr. Joachim Labenz, Co-chair of the Board of the Hospital Gastroenterology Consultants working group (ALGK),   Study centers (in order of endoscopy numbers submitted),   Prof. Dr. Andrea May, Prof. Dr. Christian Ell, Sana Klinikum Offenbach, Medical Clinic II, Offenbach,   Dr. Mark Ellrichmann, University Hospital Schleswig-Holstein, Clinic for Internal Medicine 1, Kiel,   Prof. Dr. Dieter Schilling, Diakonissenkrankenhaus Mannheim, Medical Clinic II, Mannheim,   Anton Kreuzmayr, MD, Traunstein Hospital, Clinic for Internal Medicine and Gastroenterology, Traunstein, Germany,   Prof. Dr. Volker, Schmitz, Dr. Clemens Ballmann, St. Marienwörth Hospital, Internal Medicine, Bad Kreuznach,   Prof. Dr. Christian von Tirpitz, Sana Kliniken Landkreis Biberach, Medical Clinic, Biberach,   Prof. Dr. Claus Schäfer, Klinikum Neumarkt, Medical Clinic II, Neumarkt,   Prof. Dr. Rainer Porschen, Klinikum Bremen-Ost, Internal Medicine, Bremen,   Dr. Christoph Vogt, St. Josef Hospital Moers, Internal Medicine, Moers,   Prof. Dr. Thomas Rabenstein, Diakonissen-Stiftungs-Krankenhaus Speyer, Clinic for Internal Medicine, Speyer,   Dr. Matthias Maier, Knappschaftsklinikum Saar, Internal Medicine, Püttlingen,   Dr. Claus Benz, Evangelisches Klinikum Köln-Weyertal, Internal Medicine, Cologne,   Dr. Werner Hoffmann, St. Anna Hospital, Medical Clinic II, Herne,   Prof. Dr. Mathias Plauth, Dr. Jens-Uwe Jetschmann, Dessau Clinic, Department of Internal Medicine, Gastroenterology, Dessau,   Prof. Dr. Christoph Sarrazin, Dr. Thomas, Müller, St. Josefs Hospital, Medical Clinic II, Wiesbaden,   PD Dr. Oliver Al-Taie, Sankt Elisabeth-Hospital, Medical Clinic, Gütersloh,   Prof. Dr. Thomas Frieling, Helios Klinikum Krefeld, Internal Medicine II, Krefeld,   Prof. Dr. Irmtraut Koop, Ev. Amalie Sieveking Hospital, General Internal Medicine and Gastroenterology, Hamburg,   Prof. Dr. Gerhard Kleber, Ostalb Klinikum, Internal Medicine I, Aalen,   PD Dr. Arthur Hoffman, Prof. Dr. Wolfgang Fischbach, Klinikum Aschaffenburg-Alzenau e. V., Medical Clinic II, Aschaffenburg,   PD Dr. Matthias Bahr, Dr. Eike Burmester, Medical Clinic I, Sana Kliniken Lübeck, Lübeck,   Dr. Ronni Veitt, Elisabeth Clinic Schmalkalden, Clinic for Internal Medicine I – Gastroenterology, Internal Oncology, Schmalkalden,   Prof. Dr. Ralf Kiesslich, Dr. Horst Schmidt Clinics, Clinic for Internal Medicine and Gastroenterology, Wiesbaden,   Prof. Dr. Franz Ludwig Dumoulin, Bonn Community Hospital, General Internal Medicine, Gastroenterology and Diabetology, Bonn,   Prof. Dr. Martin Krüger, Protestant Hospital Bethel, Clinic for Internal Medicine and Gastroenterology, Bielefeld,   Dr. Jens Kühne, Pius Hospital, Clinic for Internal Medicine, Oldenburg,   Prof. Dr. Till Wehrmann, DKD Helios Clinic Wiesbaden, Gastroenterology, Wiesbaden,   Prof. Dr. Christian Pehl, Vilsbiburg Hospital, Internal Medicine, Vilsbiburg,   Prof. Dr. Dr. med. Karsten-H. Weylandt, Ruppiner Kliniken, Medical Clinic B, Neuruppin,   Statistical analysis,   Dr. Jan Multmeier, Berlin
Published: January 2023

Abstract
Introduction Worldwide, gastrointestinal endoscopies are predominantly performed under sedation. National and international guidelines and recommendations contain very different specifications for the use of sedation in gastrointestinal endoscopy. These differences come from specific requirements for staffing during endoscopy.
Aim The aim of the study is to evaluate whether endoscopist-guided sedation without additional sedation assistance is not inferior to endoscopist-guided sedation with additional sedation assistance with respect to the rate of sedation-associated complications in a defined low-risk population (low-risk procedure and low-risk patient).
Methods Prospective, multicenter, randomized study.
Results 27 German study centers participated in the study. A total of 30 569 endoscopies were recorded during the study period from 1.8.2015 to 10.3.2020. The final data analysis included 28 673 examinations (64.1 % esophagosgastroduodenoscopies and 35.9 % colonoscopies). In 307 (1.1 %) examinations, 322 sedation-associated complications occurred. Of these, 321 (1.1 %) were minor complications and one (0.003 %) was a major complication. There was no statistically significant difference in the frequency of sedation-associated complications between endoscopist-guided sedation with versus without additional sedation assistance. Within the legal framework, a “shadow” sedation assistant was present in the study group without sedation assistance. This assistant intervened because of sedation-associated complications in 101 (0.7 %) of the endoscopies.
Conclusion The study documents the safety of propofol-based endoscopist-guided sedation in a low-risk population. In 98.9 % of all endoscopies, no sedation-associated complication occurred or it was so minimal that no intervention (e. g., increase of oxygen supply) was necessary. The study cannot answer to what extent a serious complication was avoided by the active intervention of the “shadow” sedation assistance in the group without sedation assistance.The study proves in a randomized, prospective design that sedation in low-risk endoscopy (low-risk patient, low-risk procedure) can be performed as endoscopist-guided sedation without additional sedation assistance, without demonstrably accepting a reduction in safety.