Comparing the Efficacy of Dexmedetomidine-Fentanyl and Midazolam-Fentanyl for Sedation during Extracorporeal Shock Wave Lithotripsy (ESWL): A Prospective Randomized Controlled Trial

Abstract

Objective : To compare the efficacy of dexmedetomidine plus fentanyl (Dex-Fen) versus midazolam plus fentanyl (MDZ-Fen) for sedation during extracorporeal shock wave lithotripsy (ESWL) in terms of patient satisfaction, pain score, sedation level, additional drug requirement, hemodynamic effects, and adverse events.

Methods : This prospective randomized controlled trial included 90 patients equally allocated into two groups. The Dex-Fen group received dexmedetomidine 1 µg/kg over 15 minutes followed by continuous infusion 0.2–0.7 µg/kg/h with fentanyl 1 µg/kg, whereas the MDZ-Fen group received midazolam 0.05 mg/kg plus fentanyl 1 µg/kg. Blood pressure, heart rate, oxygen saturation, sedation level, and pain score were recorded during the procedure. Repeated measures were analyzed using mixed-effects models.

Result : High patient satisfaction (VAS ≥ 8) was significantly more frequent in the Dex-Fen group than in the MDZ-Fen group (88.9% vs 60.0%; adjusted OR 6.87, 95% CI 2.06–22.85; p = 0.002). Overall satisfaction score was also significantly higher in the Dex-Fen group (adjusted OR 3.93, 95% CI 1.69–9.59; p = 0.002). Although overall mean pain scores were similar between groups, a significant group-by-time interaction was observed (IRR 0.99 per 15-minute interval, 95% CI 0.98–0.99; p < 0.001), indicating a more favorable pain trajectory in the Dex-Fen group. Sedation level and recovery time were comparable. No hypotension occurred in either group. Desaturation was observed only in the MDZ-Fen group, while bradycardia was more frequent in the Dex-Fen group, but neither reached statistical significance.

Conclusion : Dexmedetomidine plus fentanyl provides higher patient satisfaction and a more favorable longitudinal pain profile than midazolam plus fentanyl, without increasing clinically significant adverse events during ESWL.