title: Safety and risk factors for difficult endoscopist-directed ERCP sedation in daily practice: a hospital-based case-control study.
abstract: BACKGROUND
  There are limited data concerning endoscopist-directed endoscopic retrograde cholangiopancreatography deep sedation. The aim of this study was to establish the safety and risk factors for difficult sedation in daily practice.
  
  
  METHODS
  Hospital-based, frequency matched case-control study. All patients were identified from a database of 1,008 patients between 2014 and 2015. The cases were those with difficult sedations. This concept was defined based on the combination of the receipt of high-doses of midazolam or propofol, poor tolerance, use of reversal agents or sedation-related adverse events. The presence of different factors was evaluated to determine whether they predicted difficult sedation.
  
  
  RESULTS
  One-hundred and eighty-nine patients (63 cases, 126 controls) were included. Cases were classified in terms of high-dose requirements (n = 35, 55.56%), sedation-related adverse events (n = 14, 22.22%), the use of reversal agents (n = 13, 20.63%) and agitation/discomfort (n = 8, 12.7%). Concerning adverse events, the total rate was 1.39%, including clinically relevant hypoxemia (n = 11), severe hypotension (n = 2) and paradoxical reactions to midazolam (n = 1). The rate of hypoxemia was higher in patients under propofol combined with midazolam than in patients with propofol alone (2.56% vs. 0.8%, p < 0.001). Alcohol consumption (OR: 2.674 [CI 95%: 1.098-6.515], p = 0.030), opioid consumption (OR: 2.713 [CI 95%: 1.096-6.716], p = 0.031) and the consumption of other psychoactive drugs (OR: 2.015 [CI 95%: 1.017-3.991], p = 0.045) were confirmed to be independent risk factors for difficult sedation.
  
  
  CONCLUSIONS
  Endoscopist-directed deep sedation during endoscopic retrograde cholangiopancreatography is safe. The presence of certain factors should be assessed before the procedure to identify patients who are high-risk for difficult sedation.
authors.affiliation: Aparato Digestivo, Hospital Morales Meseguer, España.
authors.forename: Enrique
authors.initials: E
authors.lastname: Pérez-Cuadrado Robles
authors.affiliation: Hospital Universitario Lucus Augusti.
authors.forename: Abel
authors.initials: A
authors.lastname: González Ramírez
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Lancho Seco
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Eva
authors.initials: E
authors.lastname: Martí Marqués
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Andrés
authors.initials: A
authors.lastname: Dacal Rivas
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Elena
authors.initials: E
authors.lastname: Castro Ortiz
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Roberto
authors.initials: R
authors.lastname: González Soler
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Álvarez Suárez
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Dolores
authors.initials: D
authors.lastname: Tardáguila García
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Alina
authors.initials: A
authors.lastname: López Baz
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Alexia
authors.initials: A
authors.lastname: Fernández López
authors.affiliation: Gastroenterologia, Hospital Universitario Lucus Augusti.
authors.forename: Leopoldo
authors.initials: L
authors.lastname: López Roses
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods*; D054810:Deep Sedation / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives; D008297:Male; D008874:Midazolam; D008875:Middle Aged; D061214:Patient Safety; D010820:Physicians; D015742:Propofol; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D006993:Hypnotics and Sedatives; D008874:Midazolam; D015742:Propofol