The Safety and Efficacy of Remimazolam Compared to Dexmedetomidine for Awake Tracheal Intubation by Flexible Bronchoscopy: A Randomized, Double-Blind, Controlled Trial

Abstract

Background

Remimazolam is a novel ultra-short-acting benzodiazepine sedative that has the potential to be an alternative for procedural sedation due to its rapid sedation and recovery, no accumulation effect, stable hemodynamics, minimal respiratory depression, anterograde amnesia effect, and specific antagonist. Here, we aimed to compare the safety and efficacy of remimazolam with dexmedetomidine for awake tracheal intubation by flexible bronchoscopy (ATI-FB).

Methods

Ninety patients scheduled for ATI-FB were randomly divided into three groups, each consisting of 30 cases: dexmedetomidine 0.6 µg/kg + sufentanil (group DS), remimazolam 0.073 mg/kg + sufentanil (group R₁S), or remimazolam 0.093 mg/kg + sufentanil (group R₂S). The primary outcome was the success rate of sedation. Secondary outcomes were MOAA/S scores, hemodynamic and respiratory parameters, intubation conditions, intubation time, tracheal intubation amnesia, and adverse events.

Results

The success rates of sedation in groups R₂S and DS were higher than that in group R₁S (93.3%, 86.7%, respectively, vs 58.6%; P = 0.002), and intubation conditions were better than those in group R₁S (P < 0.05). Group R₂S had shorter intubation times than groups R₁S and DS (P = 0.003), and a higher incidence of tracheal intubation amnesia than group DS (P = 0.006). No patient in the three groups developed hypoxemia or hypotension, and there were no significant differences in oligopnea, PetCO₂, or bradycardia (P > 0.05).

Conclusion

In conclusion, both DS and R₂S had higher success rates of sedation, better intubation conditions, and minor respiratory depression, but R₂S, with its shorter intubation time, higher incidence of anterograde amnesia, and ability to be antagonized by specific antagonists, may be a good alternative sedation regimen for patients undergoing ATI-FB.

Keywords:

• remimazolam
• dexmedetomidine
• difficult airways
• awake tracheal intubation

Data Sharing Statement

All data generated and analyzed in the study are available from the corresponding author (Yubo Xie) upon reasonable request. The patients’ data anonymity will be preserved before distribution.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

Our work was supported by Young Clinical Research Fund of the Chinese Stomatological Association (No. CSA-A2021-08), Special Fund of Neurotoxicity of General Anesthetics and Its Prevention and Treatment Innovation Team of the First Affiliated Hospital of Guangxi Medical University (No. YYZS2022001), Guangxi Clinical Research Center for Anesthesiology (No. GK AD22035214), and Guangxi Medical and Health Appropriate Technology Development and Popularization Project (No. S2021083).