{"title":"小剂量阿芬太尼可有效降低雷马唑仑治疗全麻患儿意识丧失的ED50：一项上下序贯分配方法的研究","authors":"Xinyuan Shi, Fuxia Yi, Hongyi Xiao, Shiyu Yu, Xiaohan Sun, Yaxin Wei, Fangli Yue, Fanceng Ji","doi":"10.2147/DDDT.S532565","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the effects of low-dose alfentanil on the 50% effective dose (ED<sub>50</sub>)/95% effective dose (ED<sub>95</sub>) of remimazolam for successful loss of consciousness during general anesthesia in pediatric patients.</p><p><strong>Patients and methods: </strong>Fifty-two pediatric patients (aged 3-12, ASA I-II) scheduled for elective surgery were divided into two groups: Group A (n=24;alfentanil 5 μg kg<sup>-1</sup> + remimazolam 0.1 mg kg<sup>-1</sup>) and Group C (n=28;saline + remimazolam 0.15 mg kg<sup>-1</sup>). The MOAA/S scale was employed for assessment. To calculate the ED50, ED95 of remimazolam for inducing loss of consciousness in pediatric patients undergoing general anesthesia. Record the monitored values (MAP, HR, SpO<sub>2</sub>) at different time points and the incidence of injection pain, hiccups, spontaneous movements, hypotension, bradycardia, respiratory depression, and overall adverse events.</p><p><strong>Results: </strong>In Group A, the ED<sub>50</sub> of remimazolam for loss of consciousness in pediatric patients was 0.212 mg kg<sup>-1</sup> (95% CI: 0.182 - 0.242 mg kg<sup>-1</sup>), significantly lower than that in Group C (0.340 mg kg<sup>-1</sup>, 95% CI: 0.295-0.388 mg kg<sup>-1</sup>, P <0.001). Similarly, the ED<sub>95</sub> in Group A was 0.265 mg kg<sup>-1</sup> (95% CI: 0.237-0.413 mg kg<sup>-1</sup>), significantly lower than that in Group C (0.434 mg kg<sup>-1</sup>, 95% CI: 0.387-0.737 mg kg<sup>-1</sup>, P <0.001). The overall incidence of adverse reactions was 8.3% in Group A, significantly lower than the 39.3% in Group C (P = 0.012). Compared with baseline values at T0, the MAP of pediatric patients in both groups decreased at T2 (P<0.05), but the reduction remained within 20% of the baseline values.</p><p><strong>Conclusion: </strong>Low-dose alfentanil (5 μg kg<sup>-1</sup>) significantly reduces the ED<sub>50</sub> and ED<sub>95</sub> of remimazolam for successful loss of consciousness during paediatric general anaesthesia induction and decreases the incidence of adverse reactions during remimazolam induced sedation.</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"7459-7466"},"PeriodicalIF":5.1000,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12405720/pdf/","citationCount":"0","resultStr":"{\"title\":\"Low-Dose Alfentanil Effectively Reduces the ED50 of Remimazolam for Loss of Consciousness in Pediatric Patients Undergoing General Anesthesia: A Study Using Up-and-Down Sequential Allocation Method.\",\"authors\":\"Xinyuan Shi, Fuxia Yi, Hongyi Xiao, Shiyu Yu, Xiaohan Sun, Yaxin Wei, Fangli Yue, Fanceng Ji\",\"doi\":\"10.2147/DDDT.S532565\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To investigate the effects of low-dose alfentanil on the 50% effective dose (ED<sub>50</sub>)/95% effective dose (ED<sub>95</sub>) of remimazolam for successful loss of consciousness during general anesthesia in pediatric patients.</p><p><strong>Patients and methods: </strong>Fifty-two pediatric patients (aged 3-12, ASA I-II) scheduled for elective surgery were divided into two groups: Group A (n=24;alfentanil 5 μg kg<sup>-1</sup> + remimazolam 0.1 mg kg<sup>-1</sup>) and Group C (n=28;saline + remimazolam 0.15 mg kg<sup>-1</sup>). The MOAA/S scale was employed for assessment. To calculate the ED50, ED95 of remimazolam for inducing loss of consciousness in pediatric patients undergoing general anesthesia. Record the monitored values (MAP, HR, SpO<sub>2</sub>) at different time points and the incidence of injection pain, hiccups, spontaneous movements, hypotension, bradycardia, respiratory depression, and overall adverse events.</p><p><strong>Results: </strong>In Group A, the ED<sub>50</sub> of remimazolam for loss of consciousness in pediatric patients was 0.212 mg kg<sup>-1</sup> (95% CI: 0.182 - 0.242 mg kg<sup>-1</sup>), significantly lower than that in Group C (0.340 mg kg<sup>-1</sup>, 95% CI: 0.295-0.388 mg kg<sup>-1</sup>, P <0.001). Similarly, the ED<sub>95</sub> in Group A was 0.265 mg kg<sup>-1</sup> (95% CI: 0.237-0.413 mg kg<sup>-1</sup>), significantly lower than that in Group C (0.434 mg kg<sup>-1</sup>, 95% CI: 0.387-0.737 mg kg<sup>-1</sup>, P <0.001). The overall incidence of adverse reactions was 8.3% in Group A, significantly lower than the 39.3% in Group C (P = 0.012). Compared with baseline values at T0, the MAP of pediatric patients in both groups decreased at T2 (P<0.05), but the reduction remained within 20% of the baseline values.</p><p><strong>Conclusion: </strong>Low-dose alfentanil (5 μg kg<sup>-1</sup>) significantly reduces the ED<sub>50</sub> and ED<sub>95</sub> of remimazolam for successful loss of consciousness during paediatric general anaesthesia induction and decreases the incidence of adverse reactions during remimazolam induced sedation.</p>\",\"PeriodicalId\":11290,\"journal\":{\"name\":\"Drug Design, Development and Therapy\",\"volume\":\"19 \",\"pages\":\"7459-7466\"},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2025-08-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12405720/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Design, Development and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/DDDT.S532565\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S532565","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
Low-Dose Alfentanil Effectively Reduces the ED50 of Remimazolam for Loss of Consciousness in Pediatric Patients Undergoing General Anesthesia: A Study Using Up-and-Down Sequential Allocation Method.
Purpose: To investigate the effects of low-dose alfentanil on the 50% effective dose (ED50)/95% effective dose (ED95) of remimazolam for successful loss of consciousness during general anesthesia in pediatric patients.
Patients and methods: Fifty-two pediatric patients (aged 3-12, ASA I-II) scheduled for elective surgery were divided into two groups: Group A (n=24;alfentanil 5 μg kg-1 + remimazolam 0.1 mg kg-1) and Group C (n=28;saline + remimazolam 0.15 mg kg-1). The MOAA/S scale was employed for assessment. To calculate the ED50, ED95 of remimazolam for inducing loss of consciousness in pediatric patients undergoing general anesthesia. Record the monitored values (MAP, HR, SpO2) at different time points and the incidence of injection pain, hiccups, spontaneous movements, hypotension, bradycardia, respiratory depression, and overall adverse events.
Results: In Group A, the ED50 of remimazolam for loss of consciousness in pediatric patients was 0.212 mg kg-1 (95% CI: 0.182 - 0.242 mg kg-1), significantly lower than that in Group C (0.340 mg kg-1, 95% CI: 0.295-0.388 mg kg-1, P <0.001). Similarly, the ED95 in Group A was 0.265 mg kg-1 (95% CI: 0.237-0.413 mg kg-1), significantly lower than that in Group C (0.434 mg kg-1, 95% CI: 0.387-0.737 mg kg-1, P <0.001). The overall incidence of adverse reactions was 8.3% in Group A, significantly lower than the 39.3% in Group C (P = 0.012). Compared with baseline values at T0, the MAP of pediatric patients in both groups decreased at T2 (P<0.05), but the reduction remained within 20% of the baseline values.
Conclusion: Low-dose alfentanil (5 μg kg-1) significantly reduces the ED50 and ED95 of remimazolam for successful loss of consciousness during paediatric general anaesthesia induction and decreases the incidence of adverse reactions during remimazolam induced sedation.
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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