Remimazolam versus propofol in combination with esketamine for surgical abortion : a double-blind randomized controlled trial

Abstract

Remimazolam is a new benzodiazepine with a short half-life, good efficacy, and safety profiles in general anesthesia. Combining esketamine with propofol (P + E) could reduce propofol consumption and injection pain. It is, however, unclear if a low dose of remimazolam co-administrated with esketamine (R + E) is comparable to the increasingly used P + E for surgical abortion with general anesthetic. We conducted a double-blind randomized controlled trial to compare the efficacy and safety of R + E and P + E. Two hundred patients scheduled for a surgical abortion were randomized to receive remimazolam 0.3 mg/kg plus esketamine 0.3 mg/kg (R + E), and propofol 2 mg/kg plus esketamine 0.3 mg/kg (P + E). Sedative effectiveness was evaluated by measuring the time to lose consciousness (LOC), recovery time, and successful sedation rate. Safety was assessed by hemodynamics and adverse events during and postoperation. The time to LOC and recovery time in R + E was 5 s shorter and 1 min longer than that in P + E, respectively (both p < 0.001). Success sedation rate did not differ between groups (p = 0.73). Bradycardia incidence and injection site pain were less frequent in the R + E group than that in the P + E group. More rash was observed in the R + E group compared with the P + E group (32% vs. 5%, p < 0.001), but all were mild (only chest rash) and resolved subsequently. Low dose of remimazolam when combined with esketamine has favorable profiles with rapid onset and recovery, but mild hemodynamic side effects and adverse events. It can be used as an alternative for surgical abortion with general anesthetic.