Comparison of the Anesthetic Efficacy and Recovery Quality of Remimazolam Besylate versus Sevoflurane for Pediatric Circumcision: A Single-Center, Prospective, Randomized Controlled Study Protocol

Background: Administering anesthesia for circumcision in children involves prioritizing safety, comfort, and quality of recovery. While the effectiveness of remimazolam besylate in pediatric anesthesia requires additional confirmation, sevoflurane has been linked to complications like agitation and delirium upon recovery. This research intends to evaluate the anesthetic impacts, recovery features, and safety profiles of remimazolam compared to sevoflurane in children between the ages of 3 and 12 undergoing circumcision. Additionally, it seeks to investigate the varying responses to these two anesthetic methods among different age brackets. Methods: This study conducts a prospective, randomized controlled trial at the Wanzhou District Maternal and Child Health Hospital located in Chongqing, and is based at a single center. One hundred children, ranging in age from 3 to 12 years and classified as ASA I-II, will be recruited for a painless circumcision procedure. These participants will be randomly assigned to two distinct groups: Group R, which will receive remimazolam, and Group S, designated for sevoflurane. Participants in Group R will be administered intravenous remimazolam besylate, while those in Group S will receive inhaled sevoflurane; in addition, both groups will undergo a penile root block using 1% lidocaine. The main outcomes of interest include the time taken for sedation to commence and the duration until emergence. Secondary metrics will include the effectiveness of sedation, the occurrence of intraoperative interventions, fluctuations in hemodynamics, cases of respiratory complications, and emergence delirium, all assessed through the PAED scale. Additionally, an examination of predetermined age subgroups will take place. Statistical evaluations will be carried out utilizing SPSS version 26.0, where a P-value of under 0.05 will be considered statistically significant. Ethics and Dissemination: The Reproductive Ethics Committee at the Wanzhou District Maternal and Child Health Hospital has approved this protocol (Reference No. 2024-44). Consent from the legal guardians will be secured. Findings will be shared via publications in journals and presentations at academic conferences. Trial Registration Number: This trial has been registered with the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500095974).