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.

Comparison of the Incidence of Postoperative Acute Kidney Injury Following the Administration of Remimazolam or Sevoflurane in Elderly Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial

“…We considered that the incidence of delirium was slightly higher because RMMZ is a benzodiazepine; however, in previous studies, the correlation between RMMZ and delirium remained controversial [ 29 , 30 ]. Previous studies have demonstrated that RMMZ prevents emergent delirium in children [ 31 ]. Additional large-scale studies are required to evaluate these differences.…”

Clinical Application and Research Progress of Remimazolam for Pediatric Patients

“… 21 Remimazolam can not only effectively relieve preoperative anxiety but also reduce the risk of postoperative delirium and mania in children after sevoflurane anesthesia, which contributes to shortening hospitalization, reducing the medical burden, and improving parent satisfaction. 6 , 22 Remimazolam has not been approved by the FDA for use in pediatric patients and was first approved in 2020 for general anesthesia in adults ( Figure 4 ). At present, remimazolam is only used in a few licenced health care facilities.…”

“…A prospective, double-blind, randomized, placebo-controlled study showed that the risk of delirium after anesthesia with sevoflurane was reduced by the intraoperative administration of remimazolam (0.2 mg/kg) before the end of surgery in children aged 3 to 7 years undergoing adenotonsillectomy, without prolonging recovery time in the postanesthesia care unit (PACU). 22 Mo et al 6 found that a low of remimazolam (0.1 mg/kg) significantly reduces the incidence of emergence agitation without affecting recovery and improves the safety of preschoolers undergoing day surgery after discharge. The dose‒response relationship and long-term effects of remimazolam on reducing the incidence of postoperative delirium and emergence agitation after anesthesia with sevoflurane need further assessment in the future.…”

The Role of Remimazolam in Neurosurgery and in Patients With Neurological Diseases: A Narrative Review

“…To determine whether remimazolam decreases the risk of emergence excitation in children, Yang et al 44 randomized 104 children aged 3 to 7 years having tonsillectomy to receive either 0.2 mg/kg remimazolam or saline placebo before emergence from general anesthesia; patients were assessed for emergence excitation for up to 30 minutes after anesthesia using structured scoring. Rates of emergence excitation were significantly lower in the remimazolam group compared with the placebo group (12% vs. 44%, respectively; P <0.05).…”