Exploring the ED50 and ED95 of Remimazolam for Laryngeal Mask Airway Insertion During General Anesthesia in Pediatric Strabismus Correction Surgery.

Abstract

Aim: Remimazolam, known for its rapid onset, quick metabolism, and short recovery time from sedation, offers significant advantages in clinical anesthesia. Previous studies have primarily investigated its application in adult surgical anesthesia, with less focus on its utilization in pediatric patients. Therefore, we aimed to explore the 50% effective dose (ED50) and 95% effective dose (ED95) of remimazolam for laryngeal mask airway (LMA) insertion during general anesthesia in pediatric strabismus correction surgery and investigate its dose-response relationship, thereby providing valuable reference data for safer and more rational clinical use of remimazolam.

Methods: This study included 32 patients aged 3-12 years undergoing strabismus correction surgery at Ningbo Aier Guangming Eye Hospital in 2024. The dosage of remimazolam was determined according to the Dixon 'up-and-down' sequential method: the starting induction dose was 0.2 mg/kg, with a step dose of 0.05 mg/kg. In cases of positive anesthetic effect, the subsequent patient received a reduced step dose, while in cases of negative anesthetic effect, the next subject received an increased step dose. The trial was terminated upon observing seven "positive-negative" crossover points. Furthermore, the ED50 and ED95, along with their 95% confidence intervals (95% CI) were calculated using the Probit regression analysis. Additionally, vital signs of the patients, such as peripheral oxygen (SpO2), heart rate, and blood pressure, along with the incidence of adverse events, were monitored.

Results: The ED50 of remimazolam for LMA insertion in pediatric strabismus correction surgery was 0.300 mg/kg (95% CI 0.276-0.323 mg/kg), and the ED95 was 0.369 mg/kg (95% CI 0.324-0.414 mg/kg). Throughout the surgery, SpO2, heart rate, and blood pressure remained stable without any significant fluctuations.

Conclusions: The ED50 and ED95 of remimazolam for LMA insertion in pediatric strabismus correction surgery are 0.300 mg/kg and 0.369 mg/kg, respectively. This study demonstrates that remimazolam is both safe and effective for LMA insertion during general anesthesia in pediatric strabismus correction surgery.