title: Deep sedation for endoscopic cholangiopancreatography with or without pre or intraprocedural opioids: A double-blind randomised controlled trial.
abstract: BACKGROUND
  Propofol alone or combined with opioids is considered the drug of choice for sedation during endoscopic retrograde cholangiopancreatography (ERCP).
  
  
  OBJECTIVE
  To investigate the effect of pre or intraprocedural opioids on propofol requirement during deep sedation for ERCP, and on recovery, pain and cognitive function postoperatively.
  
  
  METHODS
  Three-arm, double-blinded randomised controlled trial.
  
  
  METHODS
  Aretaieio University Hospital, February 2011 to July 2013.
  
  
  METHODS
  One hundred and eighty adults aged between 45 and 75 years.
  
  
  METHODS
  Deep sedation with propofol (target bispectral index 40 to 70) was performed. In the remifentanil group (R), patients received intranasal placebo before ERCP, and remifentanil 0.1 ml kg(-1) h(-1) (concentration 10 μg ml(-1)) during ERCP. In the fentanyl group (F), patients received intranasal fentanyl 200 μg before ERCP and placebo during ERCP. In the placebo group (P), patients received intranasal placebo before ERCP and placebo during ERCP.
  
  
  METHODS
  The primary outcome was total propofol requirement. Secondary outcomes were recovery [assessed using the Ramsay Sedation Scale score and Observer's Assessment of Alertness/Sedation Score (OAAS)] at 30 min; postoperative pain [assessed using a visual analogue pain scale (VAS; 0 to 100 mm)]; and cognitive function [assessed using a MiniMental state test (max. 25 points) 30 min before and 30 min after ERCP].
  
  
  RESULTS
  Fifty-seven patients were included in group R, 59 in group F and 57 in group P. Propofol requirements for deep sedation were similar in all groups (13 mg kg(-1); P = 0.97). Ramsay Sedation Scale scores and OAAS scores were similar in all groups (P = 0.18 and P = 0.55, respectively). Postoperative median pain VAS differed among the groups (P = 0.007): 10 in group R, 0 in group F, five in group P. Cognitive function was high pre and postprocedure (median MiniMental state test 23 to 24) and not different among the groups.
  
  
  CONCLUSIONS
  The addition of pre or intraprocedural opioids had no effect on propofol requirement for deep sedation, but patients who received fentanyl had less minor pain.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT01304342.
authors.affiliation: From the Department of Anaesthesiology (AF, II) and Endoscopic Unit, Department of Surgery, Aretaieio Hospital, Athens, Greece (AV, AP).
authors.forename: Argyro
authors.initials: A
authors.lastname: Fassoulaki
authors.forename: Ioanna
authors.initials: I
authors.lastname: Iatrelli
authors.forename: Antonios
authors.initials: A
authors.lastname: Vezakis
authors.forename: Andreas
authors.initials: A
authors.lastname: Polydorou
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods; D054810:Deep Sedation / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007430:Intraoperative Care / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D015742:Propofol / Q000008:administration & dosage; D011446:Prospective Studies
chemical_list: D000701:Analgesics, Opioid; D006993:Hypnotics and Sedatives; D015742:Propofol