Effect of Intravenous, Inhalational, or Combined Anesthesia Maintenance on Postoperative Respiratory Adverse Events in Children Undergoing Adenotonsillectomy (AmPRAEC): A Multicenter Randomized Clinical Trial

Background: General anesthetic drugs may affect the risk of postoperative respiratory adverse events (PRAEs) in children, but the effect of anesthesia maintenance strategies on these events has not yet been widely validated. In this study, we tested the hypothesis that anesthesia maintenance with propofol infusion in addition to inhalation anesthesia or alone would lead to a progressive reduction in the incidence of PRAEs. Methods: This multicenter randomized clinical trial (AmPRAEC study) enrolled 760 children aged 0-12 years who underwent adenotonsillectomy at 12 hospitals in China. Patients were randomly assigned to the intravenous anesthesia maintenance (IV group), combined intravenous-inhalation anesthesia maintenance (IVIH group), or the inhalation anesthesia maintenance (IH group). Tracheal tubes were used for airway management, with all children undergoing awake extubation. The primary outcome was PRAEs incidence in the post-anesthesia care unit. Results: A total of 760 children (median[Interquartile Range] age, 6[4-7] years; 460 boys[60.5%]) were randomized. 729 total samples were available for modified intention-to-treat analysis. The IV group had the lowest incidence of PRAEs (45 of 239 [18.8%]), followed by the IVIH group (70 of 246 [28.5%]) and the IH group (106 of 244 [43.4%]). Compared to the IH group, the IVIH group had a significantly lower risk of PRAEs (adjusted odds ratio [aOR]: 0.44; 95% CI: 0.29-0.65; number needed to treat [NNT]: 7). The IV group had significantly lower risk compared to both the IVIH group (aOR: 0.57; 95% CI: 0.36-0.90; NNT: 6) and the IH group (aOR: 0.25; 95% CI: 0.16-0.39; NNT: 3). Conclusions: Anesthesia maintenance with propofol infusion in addition to inhalation anesthesia or alone resulted in a progressive reduction in the incidence of PRAEs, propofol intravenous anesthesia maintenance should be considered for children undergoing adenotonsillectomy.