Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study.

Abstract

PurposeTo identify the effectiveness of remimazolam at the end of tonsillectomy and adenoidectomy for preventing emergence delirium in children under sevoflurane anesthesia.Patients and MethodsOne hundred and four patients aged 3–7 years scheduled for tonsillectomy and adenoidectomy under sevoflurane anesthesia were recruited. Patients were randomly assigned to receive either remimazolam 0.2 mg kg–1 (intervention, n=52) or 0.9% normal saline (control, n=52) at the end of the procedure. The primary outcome was the incidence of emergence delirium, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Secondary outcomes were peak PAED score, emergence time, postoperative pain intensity, length of postanesthesia care unit (PACU) stay, parental satisfaction, and postoperative behavior changes three days postoperatively.ResultsEmergence delirium occurred in 6 of 51 (12%) patients receiving remimazolam versus 22 of 50 (44%) patients receiving saline (risk difference 32% [95% confidence interval, 16% to 49%], relative risk 0.27 [95% confidence interval, 0.12 to 0.60]; P<0.001). The peak PAED scores (median [interquartile range]) were lower in the remimazolam group than in the saline group (7 [6–8] versus 9 [8–11], P<0.001). Likewise, parental satisfaction was improved in the remimazolam group compared with the saline group (9 [8–10] versus 8 [7–8], P<0.001). There was no difference between groups concerning postoperative pain scores, length of PACU stay, or postoperative behavior changes.ConclusionIn children undergoing tonsillectomy and adenoidectomy, administration of remimazolam 0.2 mg kg–1 at the end of the surgery, compared with 0.9% saline, resulted in a significantly lower likelihood of emergence delirium after sevoflurane anesthesia.