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

ABSTRACT

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 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 99 Group D (0.9 ± 1.2 boluses) than in 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 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

KEYWORDS:

• Moderate sedation
• dexmedetomidine
• endobronchial ultrasound
• midazolam
• randomized controlled trials

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

ANA developed the study concept.

RK, KJ and ANA contributed to study design.

All authors contributed to data collection, data analysis, manuscript drafting and critical revisions.

All authors approve of the final manuscript version and agree to be accountable for all aspects of the work.

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Additional information

Funding

This paper was not funded