Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP.
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.
Muller
Suzana
S
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.
Borowics
Silvia M
SM
Fortis
Elaine A F
EA
Stefani
Luciana C
LC
Soares
Gabriela
G
Maguilnik
Ismael
I
Breyer
Helenice P
HP
Hidalgo
Maria Paz L
MP
Caumo
Wolnei
W
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
D006993:Hypnotics and Sedatives; D020927:Dexmedetomidine; D015742:Propofol