Comparison of the anesthetic efficacy and recovery quality of remimazolam besylate versus sevoflurane for pediatric circumcision: a single-center, prospective, assessor-blinded, randomized controlled study protocol
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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 protocol describes a planned assessor-blinded randomized controlled trial 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.
Methods
This single-center, prospective, assessor-blinded, randomized controlled trial will be conducted at the Wanzhou District Maternal and Child Health Hospital. One hundred children (aged 3–12 years, ASA I-II) scheduled for painless circumcision will be randomly allocated to receive either intravenous remimazolam besylate (Group R, n = 50) or inhaled sevoflurane (Group S, n = 50) for general anesthesia. Both groups will receive a penile root block with 1% lidocaine. Primary outcomes include time to achieve general anesthesia (MOAA/S ≤ 1) and emergence time. Secondary outcomes include anesthesia success rate, intraoperative interventions, hemodynamic changes, respiratory complications, emergence delirium (PAED scale), pain scores (FLACC), and guardian anxiety levels. Due to inherent differences in drug delivery methods, only outcome assessors and data analysts will be blinded. Exploratory subgroup analyses by age (3–6 vs. 7–12 years) will be conducted but are not powered for definitive conclusions. Statistical analysis will use SPSS version 26.0 with significance at P < 0.05.
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
This trial has been registered with the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500095974; Registration date: January 15, 2025).
