Remimazolam for the prevention of emergence agitation in adults following nasal surgery under general anesthesia: a prospective randomized clinical controlled trial

Background: Remimazolam is a novel intravenous sedative/anesthetic drug that belongs to the ultra-short-acting class of benzodiazepines. The purpose of this study was to evaluate the effectiveness of postoperative use of remimazolam in preventing emergence agitation (EA) in adults following nasal surgery.

Methods: Patients who underwent nasal surgery were randomly divided into Group R and Group C. Propofol, sufentanil, and cis-atracurium were used for the induction of anesthesia, and 1.5-3.5% sevoflurane was used for the maintenance of anesthesia. At the end of the surgery, patients were randomly assigned to receive either remimazolam 0.1 mg kg^{- 1} (Group R, n = 43) or 0.9% saline (Group C, n = 43). The primary outcome was the incidence of EA, which was defined as a Riker Sedation-Agitation Scale score > 4. The secondary outcomes included the incidence of severe EA, anesthesia, surgery characteristics, adverse events, mean arterial pressure, and heart rate (at different time points).

Results: A total of 86 adult patients completed the study. The incidence of EA was lower in Group R than in Group C (21% vs. 49%, P = 0.007). The incidence of severe EA was also lower in Group R than in Group C (2% vs. 19%, P = 0.035). The maximal Sedation-Agitation Scale score during emergence was lower in Group R 4 [range 4 to 4] than in Group C 5 [range 4 to 6] (P < 0.001). In addition, the incidence of hypertension and grade of cough in Group R were lower than in Group C (P = 0.024). During emergence, the mean arterial pressure and heart rate of group R showed more stability than those in group C.

Conclusions: Postoperative intravenous infusion of 0.1 mg/kg remimazolam into adult patients undergoing nasal surgery can reduce the incidence of EA and severe EA, and provide stable hemodynamics.

Trial registration: The trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry ( www.chictr.org.cn ) (clinical trial number: ChiCTR2300075300; Principal Investigator: Gongchen Duan; date of registration: 31 August 2023; https://www.chictr.org.cn/bin/project/edit?pid=203928 ).