Impact of Varied Anesthesia Maintenance Strategies on Postoperative Respiratory Complications in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy (AmPRAEC study)：study protocol for a multicenter randomized, double-blind clinical trial

Abstract Background: Postoperative respiratory adverse events are the most common perioperative complications in pediatric anesthesia, particularly prevalent in children undergoing tonsillectomy and adenoidectomy, with an incidence rate as high as 50%. The choice of anesthetic induction regimen directly influences the incidence of respiratory adverse events during the induction period. However, this effect seems to have minimal impact on postoperative outcomes. The occurrence rate of postoperative respiratory adverse events is likely more closely associated with the anesthetic maintenance phase, yet this relationship remains uncertain at present. Methods: The objective of this study was to assess the impact of different anesthetic maintenance regimens on postoperative respiratory adverse events in pediatric patients undergoing tonsillectomy and adenoidectomy. The AmPRAEC study is a multicenter, randomized, double-blind controlled trial. A total of 717 pediatric patients were recruited from 12 medical centers and randomly assigned to three groups: Group A (Intravenous Maintenance Group, receiving propofol infusion); Group B (Intravenous-Inhalational Combination Group, maintained with 1% sevoflurane combined with propofol); and Group C (Inhalational Maintenance Group, maintained with 2-3% sevoflurane inhalation). The primary outcome measure was the incidence rate of postoperative respiratory adverse events. Discussion:This clinical trial aims to elucidate the impact of various anesthetic maintenance regimens on postoperative respiratory adverse events in pediatric patients. The outcomes of this study are anticipated to facilitate anesthesiologists in devising more comprehensive perioperative management strategies, enhancing the comfort and improving the clinical outcomes for this patient population. Trial registration: The study protocol was registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn) with registration number: ChiCTR2300074803 on August 16, 2023.