Safety analysis of endoscopist-directed propofol sedation: A prospective, national multicenter study of 24 441 patients in German outpatient practices

Andreas Sieg, Sebastian Beck, Sabine G. Scholl, Franz J. Heil, Daniel N. Gotthardt, Wolfgang Stremmel, Douglas Rex, Kilian Friedrich

Research output: Contribution to journalArticle

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Abstract

Background and Aim: Since 2008, there exists a German S3-guideline allowing non-anesthesiological administration of propofol for gastrointestinal endoscopy. In this prospective, national, multicenter study, we evaluated the safety of endoscopist-administered propofol sedation (EDP) in German outpatient practices of Gastroenterology. Methods: In this multicenter survey of 53 ambulatory practices of Gastroenterology, we prospectively evaluated 24441 patients that had received EDP. We recorded adverse events during the endoscopic procedure and additionally retrieved questionnaires investigating subjective parameters 24h after the endoscopic procedure. Results: In 24441 patients 13793 colonoscopies, 6467 esophagogastroduodenoscopies, and 4181 double examinations were performed. In this study, 52.1% of the patients received propofol mono-sedation, and 47.9% received a combination of midazolam and propofol. Major adverse events occurred in four patients (0.016%) enrolled to this study (three mask ventilations and one laryngospasm). Minor adverse events were observed in 112 patients (0.46%) with hypoxemia being the most common minor event. All patients with adverse events recovered without persistent impairment. Minor adverse events occurred more frequently in patients sedated with propofol mono compared to propofol and midazolam (P<0.0001) and correlated with increasing propofol dosages (P<0.001; Pearson correlation coefficient r=0.044). Twenty-four hours after the endoscopy, patients sedated with propofol plus midazolam stated a significantly reduced sensation of pain (P<0.01) and improved symptoms of dizziness, nausea and vomiting (P<0.001) compared to patients having received propofol mono-sedation. Conclusion: Four years after the implementation of a German S3-Guideline for endoscopic sedation, we demonstrated that EDP is a safe procedure.

Original languageEnglish
Pages (from-to)517-523
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume29
Issue number3
DOIs
StatePublished - 2014

Fingerprint

Propofol
Multicenter Studies
Outpatients
Safety
Midazolam
Gastroenterology
Laryngismus
Guidelines
Digestive System Endoscopy
Gastrointestinal Endoscopy
Hypesthesia
Dizziness
Colonoscopy
Masks
Nausea
Endoscopy
Vomiting
Pain

Keywords

  • Adverse events
  • EDP
  • Endoscopic sedation
  • Endoscopist-directed propofol sedation
  • Outpatient endoscopy
  • Propofol and midazolam sedation
  • Propofol mono sedation
  • Safety analysis

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Safety analysis of endoscopist-directed propofol sedation : A prospective, national multicenter study of 24 441 patients in German outpatient practices. / Sieg, Andreas; Beck, Sebastian; Scholl, Sabine G.; Heil, Franz J.; Gotthardt, Daniel N.; Stremmel, Wolfgang; Rex, Douglas; Friedrich, Kilian.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 29, No. 3, 2014, p. 517-523.

Research output: Contribution to journalArticle

Sieg, Andreas ; Beck, Sebastian ; Scholl, Sabine G. ; Heil, Franz J. ; Gotthardt, Daniel N. ; Stremmel, Wolfgang ; Rex, Douglas ; Friedrich, Kilian. / Safety analysis of endoscopist-directed propofol sedation : A prospective, national multicenter study of 24 441 patients in German outpatient practices. In: Journal of Gastroenterology and Hepatology (Australia). 2014 ; Vol. 29, No. 3. pp. 517-523.
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abstract = "Background and Aim: Since 2008, there exists a German S3-guideline allowing non-anesthesiological administration of propofol for gastrointestinal endoscopy. In this prospective, national, multicenter study, we evaluated the safety of endoscopist-administered propofol sedation (EDP) in German outpatient practices of Gastroenterology. Methods: In this multicenter survey of 53 ambulatory practices of Gastroenterology, we prospectively evaluated 24441 patients that had received EDP. We recorded adverse events during the endoscopic procedure and additionally retrieved questionnaires investigating subjective parameters 24h after the endoscopic procedure. Results: In 24441 patients 13793 colonoscopies, 6467 esophagogastroduodenoscopies, and 4181 double examinations were performed. In this study, 52.1{\%} of the patients received propofol mono-sedation, and 47.9{\%} received a combination of midazolam and propofol. Major adverse events occurred in four patients (0.016{\%}) enrolled to this study (three mask ventilations and one laryngospasm). Minor adverse events were observed in 112 patients (0.46{\%}) with hypoxemia being the most common minor event. All patients with adverse events recovered without persistent impairment. Minor adverse events occurred more frequently in patients sedated with propofol mono compared to propofol and midazolam (P<0.0001) and correlated with increasing propofol dosages (P<0.001; Pearson correlation coefficient r=0.044). Twenty-four hours after the endoscopy, patients sedated with propofol plus midazolam stated a significantly reduced sensation of pain (P<0.01) and improved symptoms of dizziness, nausea and vomiting (P<0.001) compared to patients having received propofol mono-sedation. Conclusion: Four years after the implementation of a German S3-Guideline for endoscopic sedation, we demonstrated that EDP is a safe procedure.",
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AU - Stremmel, Wolfgang

AU - Rex, Douglas

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