Remimazolam Bolus Prevents Emergence Agitation After Rhinologic Surgery: A Randomized, Triple-Blind, Controlled Trial

Background/Objectives: Emergence agitation (EA) is common after rhinologic surgery and may cause self-injury, bleeding, and prolonged post-anesthesia care unit (PACU) stay. Remimazolam is an ultra-short-acting benzodiazepine that may reduce EA without delaying recovery. The objective of this study was to evaluate the effect of a single dose of remimazolam administered at the end of surgery on the incidence of EA in adult patients undergoing nasal surgery. Methods: In this prospective, randomized, triple-blind, placebo-controlled trial, 62 adults undergoing elective rhinologic surgery under sevoflurane anesthesia received either remimazolam 0.1 mg/kg or saline immediately after sevoflurane discontinuation and before extubation. EA was assessed using the Richmond Agitation-Sedation Scale (RASS) at extubation and every 5 min for 30 min in the PACU. The primary outcome was presence of EA (RASS ≥ 2) at extubation. Secondary outcomes included Aldrete recovery scores, VAS, PONV incidence and safety outcomes. The study was registered at ClinicalTrials.gov (NCT06398275; 3 May 2024). Results: EA occurred in 12/32 patients (37.5%) in the control group and 0/30 (0%) in the remimazolam group (p < 0.001). Extubation time and operative durations were similar between groups. More patients in the remimazolam group achieved an Aldrete score ≥ 9 at extubation (76.7% vs. 50.0%, p = 0.030). Severe agitation (RASS ≥ 3) requiring rescue sedation occurred in 6/32 control-group patients and in 0/30 patients in the remimazolam group (p = 0.025). Pain scores were low (no VAS > 2). PONV occurred in one patient per group. Clinically relevant postoperative nasal bleeding requiring intervention occurred in 2/32 control-group patients and in 0/30 remimazolam-group patients. No laryngospasm or respiratory complications within 24 h were observed. Conclusions: A single remimazolam bolus given at the end of surgery prevented clinically relevant EA after rhinologic surgery without delaying early recovery.