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

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 24 441 patients that had received EDP. We recorded adverse events during the endoscopic procedure and additionally retrieved questionnaires investigating subjective parameters 24 h after the endoscopic procedure.
RESULTS: In 24 441 patients 13 793 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.