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

TL;DR

A single dose of remimazolam at the end of nasal surgery prevents agitation after waking up from anesthesia without slowing recovery.

Contribution

This study shows remimazolam effectively prevents emergence agitation after rhinologic surgery in a controlled clinical trial.

Findings

Remimazolam reduced emergence agitation to 0% compared to 37.5% in the control group.

More patients in the remimazolam group achieved higher Aldrete scores at extubation.

No severe agitation or respiratory complications were observed in the remimazolam group.

Abstract

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.

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