title: Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP.
abstract: BACKGROUND
  Propofol is an accepted method of sedation for an ERCP and generally achieves deep sedation rather than conscious sedation, and dexmedetomidine has sedative properties of equivalent efficacy.
  
  
  OBJECTIVE
  To examine the hypothesis that dexmedetomidine is as effective as propofol combined with fentanyl for providing conscious sedation during an ERCP.
  
  
  METHODS
  Randomized, blind, double-dummy clinical trial.
  
  
  METHODS
  Twenty-six adults, American Society of Anesthesiologists status I to III, underwent an ERCP.
  
  
  METHODS
  Patients were randomized to receive either propofol (n = 14) (target plasma concentration range 2-4 microg/mL) combined with fentanyl 1 microg/kg, or dexmedetomidine (n = 12) 1 microg/kg for 10 minutes, followed by 0.2 to 0.5 microg/kg/min. Additional sedatives were used if adequate sedation was not achieved at the maximum dose allowed.
  
  
  METHODS
  The sedation level was assessed by the Richmond alertness-sedation scale and the demand for additional sedatives. Furthermore, heart rate, blood pressure, oxygen saturation, and respiratory rate were continuously assessed.
  
  
  RESULTS
  The relative risk (RR) was 2.71 (95% CI, 1.31-5.61) and the number of patients that needed to be treated (NNT) was 1.85 (95% CI, 1.19-4.21) to observe one additional patient with drowsiness 15 minutes after sedation in the dexmedetomidine group. Also, the RR was 9.42 (95% CI, 1.41-62.80), and the NNT was 1.42 (95% CI, 1.0-2.29) to require additional analgesic. However, there was also a greater reduction in blood pressure, a lower heart rate, and greater sedation after the procedure.
  
  
  CONCLUSIONS
  Dexmedetomidine alone was not as effective as propofol combined with fentanyl for providing conscious sedation during an ERCP. Furthermore, dexmedetomidine was associated with greater hemodynamic instability and a prolonged recovery.
authors.affiliation: Anesthesia and Perioperative Medicine Service, Gastroenterology Division, Hospital de Clínicas de Porto Alegre, Institute of Basic Health Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
authors.forename: Suzana
authors.initials: S
authors.lastname: Muller
authors.forename: Silvia M
authors.initials: SM
authors.lastname: Borowics
authors.forename: Elaine A F
authors.initials: EA
authors.lastname: Fortis
authors.forename: Luciana C
authors.initials: LC
authors.lastname: Stefani
authors.forename: Gabriela
authors.initials: G
authors.lastname: Soares
authors.forename: Ismael
authors.initials: I
authors.lastname: Maguilnik
authors.forename: Helenice P
authors.initials: HP
authors.lastname: Breyer
authors.forename: Maria Paz L
authors.initials: MP
authors.lastname: Hidalgo
authors.forename: Wolnei
authors.initials: W
authors.lastname: Caumo
mesh_terms: D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods*; D016292:Procedural Sedation / Q000379:methods*; D020927:Dexmedetomidine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000627:therapeutic use*; D007275:Injections, Intravenous; D007430:Intraoperative Care / Q000379:methods*; D008297:Male; D008875:Middle Aged; D015742:Propofol / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D006993:Hypnotics and Sedatives; D020927:Dexmedetomidine; D015742:Propofol