title: Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study.
abstract: BACKGROUND
  Deep sedation with propofol and an opioid is commonly used for ERCP but is associated with increased risk and may require the presence of an anesthesiologist. Delivery of propofol and a short-acting, potent opioid analgesic remifentanil by patients to themselves (patient-controlled sedation, PCS) could be another option. Comparative studies with propofol PCS for ERCP are lacking.
  
  
  OBJECTIVE
  To compare PCS with propofol/remifentanil to anesthesiologist-managed propofol sedation.
  
  
  METHODS
  Prospective, randomized, controlled human trial.
  
  
  METHODS
  University hospital.
  
  
  METHODS
  This study involved 80 patients presenting for elective ERCP.
  
  
  METHODS
  Patients were randomized to PCS with propofol/remifentanil (PCS group) or anesthesiologist-managed propofol sedation (propofol infusion group). Sedation level was estimated every 5 minutes throughout the procedure by using Ramsay and Gillham sedation scores. The total amount of propofol was calculated at the end of the procedure. Endoscopist and patient satisfaction with the procedures was evaluated with a structured questionnaire.
  
  
  METHODS
  Patient vital signs, amount of consumed propofol, sedation levels, and degree of endoscopist and patient satisfaction.
  
  
  RESULTS
  PCS was successful with 38 of 40 (95%) ERCP patients. In the PCS group, the mean (±standard deviation) level of sedation was markedly lighter and propofol consumption significantly smaller (175±98 mg) than in the propofol infusion group (249±138 mg) (P<.01). Degrees of patient and endoscopist satisfaction were equally high in both groups. All of the patients preferred the same sedation method should a repeat ERCP be required.
  
  
  CONCLUSIONS
  Single-center study.
  
  
  CONCLUSIONS
  PCS with propofol/remifentanil is a suitable and well-accepted sedation method for ERCP. Anesthesiologist-managed propofol sedation with constant propofol infusion is associated with unnecessary deep sedation without any impact on the degree of patient or endoscopist satisfaction. Further larger-scale studies are needed to assess the safety of PCS in ERCP patients. (
  
  
  BACKGROUND
  NCT01079312.).
authors.affiliation: Department of Anesthesia and Intensive Care Medicine, Helsinki University Central Hospital, Helsinki, Finland. maxim.mazanikov@hus.fi
authors.forename: Maxim
authors.initials: M
authors.lastname: Mazanikov
authors.forename: Marianne
authors.initials: M
authors.lastname: Udd
authors.forename: Leena
authors.initials: L
authors.lastname: Kylänpää
authors.forename: Outi
authors.initials: O
authors.lastname: Lindström
authors.forename: Pekka
authors.initials: P
authors.lastname: Aho
authors.forename: Jorma
authors.initials: J
authors.lastname: Halttunen
authors.forename: Martti
authors.initials: M
authors.lastname: Färkkilä
authors.forename: Reino
authors.initials: R
authors.lastname: Pöyhiä
mesh_terms: D016058:Analgesia, Patient-Controlled / Q000379:methods*; D018686:Anesthetics, Intravenous / Q000008:administration & dosage; D002760:Cholangiopancreatography, Endoscopic Retrograde; D016292:Procedural Sedation / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage*; D011379:Prognosis; D015742:Propofol / Q000008:administration & dosage*; D011446:Prospective Studies; D000077208:Remifentanil
chemical_list: D018686:Anesthetics, Intravenous; D010880:Piperidines; D000077208:Remifentanil; D015742:Propofol