End-of-Surgery Remimazolam Bolus Reduces Emergence Delirium in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized, Triple-Blind, Placebo-Controlled Trial.

Background/

Objectives

Emergence delirium (ED) is common after sevoflurane anesthesia in children undergoing otolaryngologic surgery. Remimazolam is an ultra-short-acting benzodiazepine that may reduce ED without delaying recovery. This study evaluated the effect of a single remimazolam bolus administered at the end of surgery on ED in children undergoing tonsillectomy and/or adenoidectomy.

Methods

In this prospective, randomized, triple-blind, placebo-controlled trial, 110 children aged 3-9 years with American Society of Anesthesiologists physical status I received remimazolam 0.1 mg/kg (n = 57) or an equal volume of normal saline (n = 53) immediately after discontinuation of sevoflurane and before extubation. The primary outcome was ED at extubation, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score ≥ 10. Secondary outcomes included Face, Legs, Activity, Cry, and Consolability (FLACC) scores, emergence time, early recovery, postoperative vomiting, and airway complications.

Results

ED occurred in 1 of 57 children (1.8%) receiving remimazolam and in 11 of 53 children (20.8%) receiving placebo (p = 0.002). The absolute risk reduction was 19.0% (95% confidence interval [CI], 7.5-31.8), the relative risk was 0.08 (95% CI, 0.01-0.63), and the number needed to treat was 6. The overall distribution of FLACC scores at extubation differed between groups (p = 0.047), with FLACC scores of 0 occurring more frequently in the remimazolam group. Median emergence time was 10 min in both groups, and all children achieved a modified Aldrete score > 8 within 15 min. Postoperative vomiting was assessed through 30 min; the comparison at 5 min showed no significant between-group difference. Airway complications also did not differ significantly between groups.

Conclusions

A single intravenous bolus of remimazolam 0.1 mg/kg administered at the end of surgery significantly reduced PAED-defined ED without prolonging emergence or delaying early postoperative recovery.