Fixed dexmedetomidine infusion versus fixed-dose midazolam bolus as primary sedative for maintaining intra-procedural sedation during endobronchial ultrasound-guided transbronchial needle aspiration: a double blind randomized controlled trial.

Objective: The utility and safety of fixed dexmedetomidine infusion was compared to fixed-dose midazolam bolus among patients undergoing EBUS-TBNA.Methods: In this randomized double-blind parallel-group study, 197 patients were assigned to receive dexmedetomidine (Group D, 1 µg/kg before, and 0.6 µg/kg/hour during, procedure) or midazolam (Group M, 2 mg before procedure) sedation. The primary outcome was number of rescue midazolam boluses administered to achieve Ramsay Sedation Scale (RSS) score of two or more. We also studied sedation depth during procedure, adverse hemodynamic and hypoxemic events, bronchoscopist and patient satisfaction, and time-to-discharge from recovery room.Results: Rescue midazolam requirement was significantly lesser in the 99 Group D (0.9±1.2 boluses) than in the 98 Group M (2.0±2.4 boluses), subjects. Mean RSS score was significantly higher in Group D subjects (2.5±0.7 vs. 2.3±0.7). Significantly more subjects in Group D developed hypotension (46 vs. 27) or bradycardia (37 vs. 5), but none required specific intervention. Bronchoscopists reported significantly greater overall procedure satisfaction in Group D subjects.Conclusion: Fixed dexmedetomidine infusion statistically significantly reduced need for rescue sedation during EBUS-TBNA, and allowed slightly faster post-procedure recovery, as compared to fixed-dose midazolam bolus. However, it caused hypotension and bradycardia more frequently.Clinical trial registration: www.clinicaltrials.gov identifier is NCT02713191.