Comparison of the ED50 of Ciprofol Combined With or Without Fentanyl for Laryngeal Mask Airway Insertion in Children: A Prospective, Randomized, Open-Label, Dose-Response Trial.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2024-10-05 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S466603

Sicong Wang, Yan Li, Fang Chen, Hua-Cheng Liu, Lezhou Pan, Wangning Shangguan

{"title":"Comparison of the ED50 of Ciprofol Combined With or Without Fentanyl for Laryngeal Mask Airway Insertion in Children: A Prospective, Randomized, Open-Label, Dose-Response Trial.","authors":"Sicong Wang, Yan Li, Fang Chen, Hua-Cheng Liu, Lezhou Pan, Wangning Shangguan","doi":"10.2147/DDDT.S466603","DOIUrl":null,"url":null,"abstract":"Purpose: This study aimed to estimate the effect of different doses of fentanyl on the median effective dose (ED50) of ciprofol for attenuating the airway and motor response to laryngeal mask airway (LMA) insertion response in healthy children.Patients and methods: 90 healthy preschool patients undergoing inguinal hernia repair surgery were randomly assigned to one of three groups: C0 (ciprofol+saline), C1 (ciprofol + fentanyl 1µg/kg), C2 (ciprofol + fentanyl 2µg/kg). Anesthesia was induced with either prepared fentanyl or saline, followed by ciprofol. The dose of ciprofol for each patient was determined using the up-and-down sequential study design. The primary outcome was the ED50 of ciprofol required for smooth LMA insertion in the three groups. Additionally, the time to loss of consciousness and any perioperative adverse events were recorded.Results: Compared with the C0 group, the ED50 (95% confidence interval) of ciprofol in the C1 and C2 groups were significantly lower (1.81 [1.73-1.90]mg/kg versus 0.67 [0.64-0.71]mg/kg and 0.48 [0.42-0.54] mg/kg, respectively; P<0.05). Additionally, the ED50 of ciprofol in the C2 group was lower than that in the C1 group (0.42 [0.42-0.54] mg/kg vs 0.67 [0.64-0.71]mg/kg; P<0.05). Furthermore, the time to loss of consciousness in the C1 and C2 groups decreased by 60% and 53%, respectively, compared to the C0 group. There were no significant differences in the incidence of drug-related hypotension after anesthesia induction among the three groups. No adverse events of hypoxia, bradycardia, or injection pain were observed in any groups.Conclusion: In healthy, non-obese Chinese children undergoing elective inguinal hernia repair surgery, fentanyl 1 µg/kg and 2 µg/kg before ciprofol injection significantly reduced the ED50 of ciprofol for attenuating LMA response, with minimal occurrence of severe side effects.","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"18 ","pages":"4471-4480"},"PeriodicalIF":4.7000,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11464411/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S466603","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: This study aimed to estimate the effect of different doses of fentanyl on the median effective dose (ED50) of ciprofol for attenuating the airway and motor response to laryngeal mask airway (LMA) insertion response in healthy children.

Patients and methods: 90 healthy preschool patients undergoing inguinal hernia repair surgery were randomly assigned to one of three groups: C0 (ciprofol+saline), C1 (ciprofol + fentanyl 1µg/kg), C2 (ciprofol + fentanyl 2µg/kg). Anesthesia was induced with either prepared fentanyl or saline, followed by ciprofol. The dose of ciprofol for each patient was determined using the up-and-down sequential study design. The primary outcome was the ED50 of ciprofol required for smooth LMA insertion in the three groups. Additionally, the time to loss of consciousness and any perioperative adverse events were recorded.

Results: Compared with the C0 group, the ED50 (95% confidence interval) of ciprofol in the C1 and C2 groups were significantly lower (1.81 [1.73-1.90]mg/kg versus 0.67 [0.64-0.71]mg/kg and 0.48 [0.42-0.54] mg/kg, respectively; P<0.05). Additionally, the ED50 of ciprofol in the C2 group was lower than that in the C1 group (0.42 [0.42-0.54] mg/kg vs 0.67 [0.64-0.71]mg/kg; P<0.05). Furthermore, the time to loss of consciousness in the C1 and C2 groups decreased by 60% and 53%, respectively, compared to the C0 group. There were no significant differences in the incidence of drug-related hypotension after anesthesia induction among the three groups. No adverse events of hypoxia, bradycardia, or injection pain were observed in any groups.

Conclusion: In healthy, non-obese Chinese children undergoing elective inguinal hernia repair surgery, fentanyl 1 µg/kg and 2 µg/kg before ciprofol injection significantly reduced the ED50 of ciprofol for attenuating LMA response, with minimal occurrence of severe side effects.

查看原文本刊更多论文

儿童喉罩气道置入时异丙酚联合或不联合芬太尼的 ED50 比较：一项前瞻性、随机、开放标签、剂量反应试验。

目的：本研究旨在估算不同剂量的芬太尼对环丙酚中位有效剂量（ED50）的影响，环丙酚可减轻健康儿童对喉罩气道（LMA）插入反应的气道和运动反应。患者和方法：90 名接受腹股沟疝修补手术的健康学龄前患者被随机分配到三组中的一组：C0（环丙酚+生理盐水）、C1（环丙酚+芬太尼 1µg/kg）、C2（环丙酚+芬太尼 2µg/kg）。先用准备好的芬太尼或生理盐水进行麻醉，然后再用环丙酚。采用上下顺序研究设计确定了每位患者的环丙酚剂量。主要结果是三组患者顺利插入 LMA 所需的环丙酚 ED50。此外，还记录了意识丧失时间和任何围手术期不良事件：结果：与 C0 组相比，C1 组和 C2 组的环丙酚 ED50（95% 置信区间）显著较低（分别为 1.81 [1.73-1.90]mg/kg 对 0.67 [0.64-0.71]mg/kg 和 0.48 [0.42-0.54] mg/kg；PC 结论：在健康非肥胖的中国儿童中，环丙酚的 ED50（95% 置信区间）显著较低：在接受腹股沟疝修补术的健康非肥胖中国儿童中，注射环丙酚前使用芬太尼1微克/千克和2微克/千克可显著降低环丙酚减弱LMA反应的ED50，且严重副作用极小。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

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.