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已发表论文
瑞马唑仑苯磺酸盐与丙泊酚用于儿童磁共振成像镇静的比较评估：安全性、恢复情况及不良事件特征
Authors Shi H, Zhu J, Liu J, Cai J, Wang L, Yan J
Received 7 June 2025
Accepted for publication 9 October 2025
Published 18 October 2025 Volume 2025:18 Pages 6315—6325
DOI https://doi.org/10.2147/IJGM.S542191
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Woon-Man Kung
Haibi Shi, Jinxian Zhu, Jieru Liu, Jun Cai, Ling Wang, Jian’e Yan
Department of Anesthesiology, Lianyungang Maternal and Child Health Hospital, Lianyungang, Jiangsu, 222000, People’s Republic of China
Correspondence: Jian’e Yan, Department of Anesthesiology, Lianyungang Maternal and Child Health Hospital, 669 Qin Dongmen Street, Haizhou District, Lianyungang, Jiangsu, 222000, People’s Republic of China, Email yanjeabc@163.com
Objective: To evaluate the safety and efficacy of remimazolam besylate compared with propofol for pediatric MRI sedation.
Methods: Seventy-nine children undergoing MRI were randomly assigned to the remimazolam (R, n=39) or propofol (P, n=40) group. The primary observation indicator was the sedation success rate. Secondary indicators included the frequency of supplemental dosing, induction time, recovery time, and the incidence of adverse events (hypoxia, severe hypoxia, injection pain, hypotension, and bradycardia). Logistic regression and Spearman correlation were used to identify risk factors for adverse events.
Results: Sedation success rates were similar between groups (R: 92.3%, P: 95.0%; P=0.977). The R group showed longer induction (51.3 ± 25.9 s vs 38.5 ± 17.5 s, P=0.012) but faster recovery (12.1 ± 3.8 min vs 15.9 ± 4.6 min, P< 0.001) and required fewer supplemental doses (≥ 2 doses: 23.1% vs 57.5%, P=0.002). Adverse events were less frequent with remimazolam. Logistic regression analysis revealed that recovery time, choice of sedative, and frequency of drug supplementation were significant risk factors for adverse events during pediatric MRI sedation. Prolonged recovery time (OR=1.454, 95% CI: 1.077– 1.962, P=0.015) increased the risk of adverse events, whereas the use of remimazolam besylate significantly reduced this risk compared to propofol (OR=0.265, 95% CI: 0.145– 0.486, P < 0.001). Patients needing ≥ 2 supplemental doses had higher risk (OR=2.188, 95% CI: 1.155– 4.145, P=0.016). After adjustment, recovery time (adjusted OR=1.384, 95% CI: 1.064– 1.800, P=0.015), ≥ 2 supplementations (adjusted OR=1.828, 95% CI: 1.267– 2.637, P=0.001), and sedative type (adjusted OR=0.435, 95% CI: 0.214– 0.883, P=0.021) remained independent predictors. Correlation analysis confirmed significant associations between recovery time, sedative choice, supplementation frequency, and adverse event occurrence (all P< 0.05).
Conclusion: Remimazolam besylate and propofol are both safe and effective for pediatric MRI sedation, but remimazolam besylate is superior due to faster recovery and fewer adverse events.
Clinical Trial Number: This study was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR), registration number: ChiCTR2500097093.
Keywords: remimazolam besylate, propofol, pediatric sedation, magnetic resonance imaging, adverse event
Department of Anesthesiology, Lianyungang Maternal and Child Health Hospital, Lianyungang, Jiangsu, 222000, People’s Republic of China
Correspondence: Jian’e Yan, Department of Anesthesiology, Lianyungang Maternal and Child Health Hospital, 669 Qin Dongmen Street, Haizhou District, Lianyungang, Jiangsu, 222000, People’s Republic of China, Email yanjeabc@163.com
Objective: To evaluate the safety and efficacy of remimazolam besylate compared with propofol for pediatric MRI sedation.
Methods: Seventy-nine children undergoing MRI were randomly assigned to the remimazolam (R, n=39) or propofol (P, n=40) group. The primary observation indicator was the sedation success rate. Secondary indicators included the frequency of supplemental dosing, induction time, recovery time, and the incidence of adverse events (hypoxia, severe hypoxia, injection pain, hypotension, and bradycardia). Logistic regression and Spearman correlation were used to identify risk factors for adverse events.
Results: Sedation success rates were similar between groups (R: 92.3%, P: 95.0%; P=0.977). The R group showed longer induction (51.3 ± 25.9 s vs 38.5 ± 17.5 s, P=0.012) but faster recovery (12.1 ± 3.8 min vs 15.9 ± 4.6 min, P< 0.001) and required fewer supplemental doses (≥ 2 doses: 23.1% vs 57.5%, P=0.002). Adverse events were less frequent with remimazolam. Logistic regression analysis revealed that recovery time, choice of sedative, and frequency of drug supplementation were significant risk factors for adverse events during pediatric MRI sedation. Prolonged recovery time (OR=1.454, 95% CI: 1.077– 1.962, P=0.015) increased the risk of adverse events, whereas the use of remimazolam besylate significantly reduced this risk compared to propofol (OR=0.265, 95% CI: 0.145– 0.486, P < 0.001). Patients needing ≥ 2 supplemental doses had higher risk (OR=2.188, 95% CI: 1.155– 4.145, P=0.016). After adjustment, recovery time (adjusted OR=1.384, 95% CI: 1.064– 1.800, P=0.015), ≥ 2 supplementations (adjusted OR=1.828, 95% CI: 1.267– 2.637, P=0.001), and sedative type (adjusted OR=0.435, 95% CI: 0.214– 0.883, P=0.021) remained independent predictors. Correlation analysis confirmed significant associations between recovery time, sedative choice, supplementation frequency, and adverse event occurrence (all P< 0.05).
Conclusion: Remimazolam besylate and propofol are both safe and effective for pediatric MRI sedation, but remimazolam besylate is superior due to faster recovery and fewer adverse events.
Clinical Trial Number: This study was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR), registration number: ChiCTR2500097093.
Keywords: remimazolam besylate, propofol, pediatric sedation, magnetic resonance imaging, adverse event