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

Abstract

Purpose: To identify the effectiveness of remimazolam at the end of tonsillectomy and adenoidectomy for preventing emergence delirium in children under sevoflurane anesthesia. Patients and Methods: One 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. Results: Emergence 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. Conclusion: In 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. Keywords.