Remimazolam: a randomized controlled study of its suitability for insertion of a supraglottic airway.

ABSTRACT

PURPOSE: Loss of motor response to thrusting the jaw forward is a useful indicator for uncomplicated insertion of a supraglottic airway. The aim of this study was to assess the suitability of remimazolam for insertion of a supraglottic airway assessed by loss of response to jaw thrusting. METHODS: Seventy patients, who were scheduled for elective surgeries under general anesthesia, were allocated randomly to one of two groups. In one group (remimazolam group), remimazolam was infused 12 mg kg-1 h-1 (50 mg maximum), and in the other (propofol group), propofol was infused at 120 mg kg-1 h-1 (500 mg maximum). Once the eyelash reflex disappeared, response to jaw thrusting was assessed. Primary outcome measure was the proportion of patients with loss of response to jaw thrusting before reaching the maximum dose of the test drug. We planned an interim analysis (of one time) after 40 patients, using the Pocock adjustment method. RESULTS: From the interim analysis results, the study was stopped after recruitment of 40 patients. Loss of response to jaw thrusting was observed in all of 21 patients (100%) in the propofol group, and in 9 of 19 patients (47%) in the remimazolam group. There was a significant difference in the proportion between the groups (P = 0.0001, 95% CI for difference 30-75%). CONCLUSION: Remimazolam frequently does not inhibit response to jaw thrusting, and thus remimazolam is not a suitable induction agent for uncomplicated insertion of a supraglottic airway unless either a neuromuscular blocking agent or an opioid is co-administered.