Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP

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Gastrointestinal Endoscopy Volume 67, Issue 4, April 2008, Pages 651-659

doi:10.1016/j.gie.2007.09.041 Copyright © 2008 American Society for Gastrointestinal Endoscopy Published by Mosby, Inc.

Original article

Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP

Suzana Muller MsS, RNa, Silvia M. Borowicsa, Elaine A.F. Fortis MD, PhDa, Luciana C. Stefani MDa, a Soaresa, Ismael Maguilnik MD, MsHa, Helenice P. Breyer MD, MsHa, Paz L. Hidalgo MD, PhDa and Wolnei Caumo MD, PhD, a aCurrent affiliations: Anesthesia and Perioperative Medicine Service (S.M.B., E.A.F.F., L.C.S., G.S., W.C.), Digestive Endoscopy Unit (S.M., I.M., H.P.B.), Gastroenterology Division, Hospital de Clínicas de Porto Alegre, Psychiatric Department of Medicine (P.L.H.), Pharmacology Department (W.C.), Institute of Basic Health Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil Received 23 July 2007; accepted 17 September 2007. Porto Alegre, Brazil. Available online 4 March 2008.

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. Design and Setting

Randomized, blind, double-dummy clinical trial. Patients

Twenty-six adults, American Society of Anesthesiologists status I to III, underwent an ERCP. Interventions

Patients were randomized to receive either propofol (n = 14) (target plasma concentration range 2-4 μg/mL) combined with fentanyl 1 μg/kg, or dexmedetomidine (n = 12) 1 μg/kg for 10 minutes, followed by 0.2 to 0.5 μg/kg/min. Additional sedatives were used if adequate sedation was not achieved at the maximum dose allowed. Main Outcomes Measurements

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.

Abbreviations: ANOVA, analysis of variance; ASA, American Society of Anesthesiologists; BP, blood pressure; ETCO2, end-tidal carbon dioxide; HR, heart rate; IQR, interquartile range; MAP, mean arterial pressure; NNT, number needed to treat; RASS, Richmond alertness-sedation scale; RR, relative risk; SpO2, oxygen saturation; TCI, target-controlled infusion

Reprint requests: Wolnei Caumo, MD, Pharmacology Department, Institute of Basic Health Sciences, Universidade Federal do Rio Grande do Sul, Rua Cel Corte Real, 295, Bairro Petropolis, 90630-080 – Porto Alegre, RS, Brazil.

Gastrointestinal Endoscopy Volume 67, Issue 4, April 2008, Pages 651-659