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Background <p>Remimazolam is a novel sedative with potential benefits for pediatric procedural sedation, but its optimal dose in combination regimens is unknown. This study aimed to compare the efficacy and safety of three different remimazolam doses combined with sufentanil and propofol for pediatric gastroscopy.</p> Methods <p>This prospective, randomized, single-center study enrolled 180 ASA physical status I-II pediatric patients (aged 3 to &lt; 18 years) undergoing gastroscopy. Patients were randomized to receive 0.2&#xa0;mg/kg (R2 group), 0.3&#xa0;mg/kg (R3 group), or 0.4&#xa0;mg/kg (R4 group) remimazolam, all with 0.1&#xa0;µg/kg sufentanil. Anesthesia was induced with remimazolam followed by titrated propofol to achieve a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) score ≤ 2. The primary outcome was total propofol consumption.</p> Results <p>Sedation success was 100%. The R3 group required significantly less propofol (42.5 ± 8.1&#xa0;mg; 1.2 ± 0.2&#xa0;mg/kg) than the R2 group (58.8 ± 9.9&#xa0;mg; 1.7 ± 0.3&#xa0;mg/kg; mean difference − 0.5&#xa0;mg/kg, 95% CI [-0.6, -0.4]; <i>P</i> &lt; 0.001) and the R4 group (50.2 ± 7.5&#xa0;mg; 1.4 ± 0.2&#xa0;mg/kg; <i>P</i> &lt; 0.001), with fewer supplemental doses (1.67%) versus the R2 group (16.67%; <i>P</i> = 0.003). The R4 group had the most pronounced decreases in blood pressure, with a higher incidence of hypotension requiring intervention (23.33%) compared to the R2 group (8.33%; <i>P</i> = 0.026). Respiratory depression was significantly less frequent in R3 (5.00%) compared to R2 (16.67%; <i>P</i> = 0.031). Injection pain was absent in the R3 and R4 groups versus 6.67% in the R2 group (<i>P</i> = 0.017). Awakening and recovery times were comparable across groups.</p> Conclusion <p>For pediatric gastroscopy, a 0.3&#xa0;mg/kg dose of remimazolam combined with sufentanil and propofol provides an optimal balance of efficacy and safety, significantly reducing propofol requirements and associated respiratory depression compared to a 0.2&#xa0;mg/kg dose, while causing less hypotension than a 0.4&#xa0;mg/kg dose. Limitations of this single-center study include the lack of a non-remimazolam comparator group and the inability to blind the anesthesiologist administering the sedative agents.</p> Trial registration <p>ClinicalTrials.gov, NCT07083440. Retrospectively registered on July 16, 2025. The first patient was enrolled on June 1, 2023.</p>

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Optimal remimazolam dosage for pediatric painless gastrointestinal endoscopy: a randomized controlled trial comparing efficacy and safety of three doses combined with sufentanil and propofol

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月2日

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  • Wenjing Chen,
  • Lei Shi,
  • Wenjuan Bao,
  • Yang Liu,
  • Jing Shi

摘要

Background

Remimazolam is a novel sedative with potential benefits for pediatric procedural sedation, but its optimal dose in combination regimens is unknown. This study aimed to compare the efficacy and safety of three different remimazolam doses combined with sufentanil and propofol for pediatric gastroscopy.

Methods

This prospective, randomized, single-center study enrolled 180 ASA physical status I-II pediatric patients (aged 3 to < 18 years) undergoing gastroscopy. Patients were randomized to receive 0.2 mg/kg (R2 group), 0.3 mg/kg (R3 group), or 0.4 mg/kg (R4 group) remimazolam, all with 0.1 µg/kg sufentanil. Anesthesia was induced with remimazolam followed by titrated propofol to achieve a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) score ≤ 2. The primary outcome was total propofol consumption.

Results

Sedation success was 100%. The R3 group required significantly less propofol (42.5 ± 8.1 mg; 1.2 ± 0.2 mg/kg) than the R2 group (58.8 ± 9.9 mg; 1.7 ± 0.3 mg/kg; mean difference − 0.5 mg/kg, 95% CI [-0.6, -0.4]; P < 0.001) and the R4 group (50.2 ± 7.5 mg; 1.4 ± 0.2 mg/kg; P < 0.001), with fewer supplemental doses (1.67%) versus the R2 group (16.67%; P = 0.003). The R4 group had the most pronounced decreases in blood pressure, with a higher incidence of hypotension requiring intervention (23.33%) compared to the R2 group (8.33%; P = 0.026). Respiratory depression was significantly less frequent in R3 (5.00%) compared to R2 (16.67%; P = 0.031). Injection pain was absent in the R3 and R4 groups versus 6.67% in the R2 group (P = 0.017). Awakening and recovery times were comparable across groups.

Conclusion

For pediatric gastroscopy, a 0.3 mg/kg dose of remimazolam combined with sufentanil and propofol provides an optimal balance of efficacy and safety, significantly reducing propofol requirements and associated respiratory depression compared to a 0.2 mg/kg dose, while causing less hypotension than a 0.4 mg/kg dose. Limitations of this single-center study include the lack of a non-remimazolam comparator group and the inability to blind the anesthesiologist administering the sedative agents.

Trial registration

ClinicalTrials.gov, NCT07083440. Retrospectively registered on July 16, 2025. The first patient was enrolled on June 1, 2023.