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Z Gastroenterol 2023; 61(12): 1593-1602
DOI: 10.1055/a-1957-7788
Originalarbeit

Safety of endoscopist-guided sedation in a low-risk collective

A randomised multicentre study (Prosed3 study)
Angelika Behrens
1   Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie und Pneumologie, Evangelische Elisabeth Klinik Krankenhausbetriebs gGmbH, Berlin, Germany
,
Christian Ell
2   Sana Klinikum Offenbach GmbH, Offenbach, Germany
,
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 › Author Affiliations NEXUS/E&L medical systems GmbH, Nürnberg
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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.

Zusammenfassung

Einleitung Weltweit werden gastrointestinale Endoskopien überwiegend in Sedierung durchgeführt. In den national und international publizierten Leitlinien und Handlungsempfehlungen fallen sehr unterschiedliche Vorgaben zur Durchführung der Sedierung in der gastrointestinalen Endoskopie auf. Diese Divergenzen betreffen insbesondere die Vorgaben zur personellen Ausstattung während der durchgeführten Endoskopie.

Ziel Das Ziel der Studie war zu überprüfen, ob die Endoskopiker-geführte Sedierung ohne zusätzliche Sedierungsassistenz in einem definierten Niedrigrisikokollektiv (Niedrigrisikoprozedur und Niedrigrisikopatient) einer Endoskopiker-geführten Sedierung mit zusätzlicher Sedierungsassistenz bezüglich der Rate von sedierungsassoziierten Komplikationen nicht unterlegen ist.

Methodik Prospektive, multizentrische, randomisierte Studie.

Ergebnis An der Studie beteiligten sich 27 deutsche Studienzentren. Insgesamt wurden 30 569 Endoskopien in dem Studienzeitraum vom 01.08.2015 bis zum 10.03.2020 erfasst. In die finale Datenanalyse gingen 28 673 Untersuchungen (64,1 % Ösophagosgastroduodenoskopien und 35,9 % Koloskopien) ein. Bei 307 (1,1 %) Untersuchungen traten 322 sedierungsassoziierte Komplikationen auf. Dabei handelte es sich bei 321 (1,1 %) Komplikationen um Minorkomplikationen und in einem Fall (0,003 %) um eine Majorkomplikation. Es zeigte sich kein statistisch signifikanter Unterschied in der Häufigkeit einer sedierungsassoziierten Komplikation zwischen einer Endoskopiker-geführten Sedierung mit versus ohne zusätzliche Sedierungsassistenz. Im Rahmen rechtlicher Vorgaben war in der Studiengruppe ohne Sedierungsassistenz eine „Schatten“-Sedierungsassistenz anwesend. Diese griff aufgrund einer sedierungsassoziierten Komplikation bei 101 (0,7 %) der Endoskopien ein.

Schlussfolgerung Die Studie dokumentiert die Sicherheit einer propofolbasierten Endoskopiker-geführten Sedierung in einem Niedrigrisikokollektiv. Bei 98,9 % aller Endoskopien trat keine sedierungsassoziierte Komplikation auf oder sie war so minimal, dass keine Intervention (z. B. Erhöhung der Sauerstoffzufuhr) notwendig wurde. Inwieweit durch das aktive Eingreifen der „Schatten“-Sedierungsassistenz in der Gruppe ohne Sedierungsassistenz eine schwerwiegende Komplikation vermieden wurde, kann die Studie nicht beantworten.

Die Studie belegt in einem randomisierten, prospektiven Design, dass die Sedierung in der Niedrigrisikoendoskopie (Niedrigrisikopatient, Niedrigrisikoprozedur) als Endoskopiker-geführte Sedierung ohne zusätzliche Sedierungsassistenz durchgeführt werden kann, ohne dass nachweisbar eine Einschränkung der Sicherheit in Kauf genommen wird.

Key words

endoscopy - sedation associated complication - propofol


Publication History

Received: 03 August 2022

Accepted: 06 October 2022

Article published online:
11 January 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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