Yueyue Chen,1 Wenhua Zhang,2 Junyi Ma,1 Wenxing Liu,1 Xingrong Song,1 Xi Chen1 

1Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangdong Provincial Clinical Research Center for Child Health, Guangzhou, People’s Republic of China; 2Department of Anesthesiology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China

Correspondence: Xi Chen, Department of Anesthesiology, Guangzhou Medical University Affiliated Women and Children’s Medical Center, Guangzhou Medical University, 9 Jinsui Road, Tianhe District, Guangdong, Guangzhou Province, 510623, People’s Republic of China, Tel +86 18620688567, Fax +86 020 38076243, Email 877579351@qq.com

Purpose: Preoperative anxiety is an urgent problem in pediatric patients. This trial evaluated intravenous remimazolam for preoperative sedation in pediatric patients, assessing efficacy, safety, and age-dependent dose effects.
Patients and Methods: In this two-part study, Aged 1~6 years old, 293 ASA I–II children [Parental Separation Anxiety Score (PSAS) ≥ 3 after nonpharmacological interventions] were enrolled. Part I: children were divided into 5 groups according to their age, and the trial was conducted by the Dixon-Massey sequential method. The first child in each group received a dose of 0.3 mg/kg of remimazolam, with a drug dose gradient of 0.05 mg/kg. Part II: 150 children were randomly selected and assigned to receive remimazolam 0.2– 0.3 mg/kg. The main observations of this study were sedation effect and safety.
Results: The ED50 and 95% confidence interval (CI) for children aged 1– 2 years was 0.14 (0.11– 0.16) mg/kg, for children aged 2– 3 years was 0.14 (0.11– 0.17) mg/kg, for children aged 3– 4 years was 0.16 (0.12– 0.19) mg/kg, and for children aged 4– 5 years was 0.14 (0.11– 0.16) mg/kg, 5– 6 years 0.13 (0.10– 0.16) mg/kg, with no significant difference between age groups (P=0.525). The ED95 for preoperative sedation in children aged 1– 6 years was 0.29 mg/kg (95% CI: 0.27– 0.40). The difference in MOAA/S scores between the different dose groups in Part II was statistically significant (p< 0.001) at 2 minutes after dosing. None of the adverse events that occurred after the use of remimazolam in this trial required the use of medication for intervention.
Conclusion: Remimazolam can be effectively used for preoperative sedation in children aged 1– 6 years with low circulatory and respiratory effects, and there was no difference in the effective dose of the drug by age.

Keywords: pediatric patient, sedation with wakefulness, dose-effect relationship, drug