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Determination of the ED90 of Remimazolam Bolus Dose for Preventing Emergence Delirium in Children with Sevoflurane
Bin Xue1, Lu Wang1,2, Chenchen Li3
1Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, People's Republic of China.
Insights
The 90% effective dose (ED90) of single-bolus remimazolam for preventing emergence delirium in pediatric patients is 0.114 mg/kg. This dose is safe and effective for children undergoing sevoflurane anesthesia.
Area of Science:
- Anesthesiology
- Pediatric Anesthesia
- Pharmacology
Background:
- Emergence delirium (ED) is common in children under sevoflurane anesthesia.
- Single-bolus remimazolam can reduce ED, but the optimal dose is unknown.
Purpose of the Study:
- To determine the 90% effective dose (ED90) of single-bolus remimazolam for preventing ED in pediatric patients.
- To establish an optimal dose for preventing emergence delirium in children.
Main Methods:
- A biased-coin design up-and-down sequential method was used to determine the ED90.
- 59 children (aged 2-12 years) undergoing laparoscopic inguinal hernia repair were included.
- The starting dose was 0.1 mg/kg, with 0.02 mg/kg intervals.
Main Results:
- The estimated ED90 of remimazolam was 0.114 mg/kg (95% CI, 0.098-0.128 mg/kg).
- The overall incidence of ED was 14.3%.
- No adverse events were observed within the tested dose range.
Conclusions:
- The ED90 of single-bolus remimazolam for preventing ED in pediatric patients is 0.114 mg/kg.
- This finding provides crucial clinical evidence for pediatric anesthesia practices.
- The study offers a methodological reference for future dose-finding research.
Purpose:
Emergence delirium (ED), a psychomotor agitation state, has a high incidence in children under sevoflurane anesthesia. Single-bolus administration of remimazolam can effectively reduce ED occurrence, similar to continuous infusion. However, the optimal single-bolus dose of remimazolam for preventing ED in children is unknown. Thus, we aimed to identify the 90% effective dose (ED90) of single-bolus dose of remimazolam for preventing ED in pediatric patients under sevoflurane anesthesia.
Patients And Methods:
Our study included 59 children (aged 2-12 years) who were scheduled to undergo elective laparoscopic inguinal hernia repair under general anesthesia. The ED90 of bolus-dose remimazolam was determined according to the biased-coin design up-and-down sequential allocation method, starting from 0.1 mg/kg (interval, 0.02 mg/kg). The primary outcome was ED90 based on the success or failure of the remimazolam bolus dose in preventing ED.
Results:
Fifty-six children were enrolled in this study. Remimazolam dose ranged from 0.06 to 0.14 mg/kg. The estimated ED90 of remimazolam for preventing ED was 0.114 mg/kg (95% confidence interval [CI], 0.098-0.128 mg/kg). The duration of the surgery was 24.4 ± 10.9 min. The patients' extubation time, recovery time, and length of stay in the post-anesthesia care unit were 10.2 ± 4.5, 23.3 ± 9.3, and 26.4 ± 7.1 min, respectively. The total incidence of ED across all enrolled patients was 14.3%. No patient experienced adverse events within the tested dose range.
Conclusion:
For children undergoing laparoscopic inguinal hernia repair surgery under inhalation anesthesia with sevoflurane, the ED90 of single-bolus remimazolam for preventing ED was 0.114 mg/kg (95% CI, 0.098-0.128 mg/kg). We believe that this study addresses an important clinical evidence gap in pediatric anesthesia while providing a rigorous methodological reference for future dose-finding research.
Clinical Trial Registration:
https://www.chictr.org.cn, registration no. ChiCTR2500104472.
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