title: Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl.
abstract: BACKGROUND
  Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation.
  
  
  OBJECTIVE
  To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE.
  
  
  METHODS
  A prospective, randomized, controlled trial was conducted between February 2008 and February 2009.
  
  
  METHODS
  Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured.
  
  
  RESULTS
  Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P < .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P < .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172).
  
  
  CONCLUSIONS
  Single-blind study; sample size.
  
  
  CONCLUSIONS
  Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.
authors.affiliation: Disciplina de Gastroenterologia Clínica, Universidade Federal de São Paulo, São Paulo, Brasil.
authors.forename: Lucianna Motta
authors.initials: LM
authors.lastname: Correia
authors.forename: Danielle Queiroz
authors.initials: DQ
authors.lastname: Bonilha
authors.forename: Gustavo Flores
authors.initials: GF
authors.lastname: Gomes
authors.forename: Juliana Ramos
authors.initials: JR
authors.lastname: Brito
authors.forename: Frank Shigueo
authors.initials: FS
authors.lastname: Nakao
authors.forename: Luciano
authors.initials: L
authors.lastname: Lenz
authors.forename: Maria Rachel Silveira
authors.initials: MR
authors.lastname: Rohr
authors.forename: Angelo P
authors.initials: AP
authors.lastname: Ferrari
authors.forename: Ermelindo Della
authors.initials: ED
authors.lastname: Libera
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D000762:Anesthesia Recovery Period; D001919:Bradycardia / Q000209:etiology; D016292:Procedural Sedation / Q000009:adverse effects / Q000379:methods*; D054810:Deep Sedation / Q000009:adverse effects / Q000379:methods*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D007022:Hypotension / Q000209:etiology; D000860:Hypoxia / Q000209:etiology; D008103:Liver Cirrhosis / Q000378:metabolism*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects; D016037:Single-Blind Method; D018709:Statistics, Nonparametric
chemical_list: D000701:Analgesics, Opioid; D006993:Hypnotics and Sedatives; D008874:Midazolam; D005283:Fentanyl; D015742:Propofol