在 Narcotrend 和 SPI 监测下,确定瑞芬太尼联合异丙酚用于宫腔镜手术全静脉麻醉的最佳剂量。

IF 3.4 3区 医学 Q2 PHARMACOLOGY & PHARMACY Therapeutic Advances in Drug Safety Pub Date : 2024-11-04 eCollection Date: 2024-01-01 DOI:10.1177/20420986241289204
Xiaoyu Zhang, Tao Xu, Xiaohu An, Jianwei Wang, Qiong Meng, Zifeng Xu
{"title":"在 Narcotrend 和 SPI 监测下,确定瑞芬太尼联合异丙酚用于宫腔镜手术全静脉麻醉的最佳剂量。","authors":"Xiaoyu Zhang, Tao Xu, Xiaohu An, Jianwei Wang, Qiong Meng, Zifeng Xu","doi":"10.1177/20420986241289204","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Outpatient hysteroscopic surgery requires patients to be anaesthetised and recover quickly, and the drugs used must be safe and effective. Remifentanil is typically co-administered with propofol as total intravenous anaesthesia (TIVA) for hysteroscopy because of its favourable pharmacokinetic and pharmacodynamic properties. However, the optimal dose of remifentanil when co-administered with propofol without neuromuscular blocking agents (NMBAs) has not been established.</p><p><strong>Objectives: </strong>In this sequential dose-finding study, the 90% effective dose (ED90) of remifentanil effect-site concentration (Ce) combined with propofol without NMBAs during outpatient hysteroscopy was calculated to minimise the side effects of using higher doses.</p><p><strong>Design: </strong>This sequential dose-finding study was conducted in August 2022.</p><p><strong>Methods: </strong>Forty patients who underwent outpatient hysteroscopy under TIVA were included in the study. With a biased coin up-and-down design, the initial remifentanil Ce was established at 2 ng/mL, and the subsequent remifentanil dosage was determined based on the reaction of the previous patient. The primary outcome was a remifentanil Ce that resulted in successful TIVA by maintaining a Narcotrend index < 60, surgical pleth index (SPI) < 50, and without patient movement throughout hysteroscopy. Secondary outcomes included rates of hypotension-related symptoms and interventions, drug consumption, post-anaesthesia care unit (PACU)-estimated visual analogue scale (VAS) and Ramsay sedation scores, modified Aldrete scores, and other adverse effects of anaesthesia. The ED90 and 95% confidence intervals (CI) were estimated using isotonic regression methods and bootstrapping.</p><p><strong>Results: </strong>For TIVA without NMBAs during outpatient hysteroscopy, the ED90 Ce of remifentanil combined with propofol was determined to be 2.75 ng/mL (95% CI, 2.50-3.00 ng/mL). The incidence of peri-operative adverse effects of anaesthesia was relatively low. All the patients had satisfactory VAS, Ramsay sedation, and modified Aldrete scores in the PACU.</p><p><strong>Conclusion: </strong>Remifentanil at a Ce of 2.75 ng/mL is recommended for TIVA combined with propofol in outpatient hysteroscopic surgery.</p><p><strong>Trial registration: </strong>http://www.chictr.org.cn (ChiCTR2200062284; 31/7/2022).</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536375/pdf/","citationCount":"0","resultStr":"{\"title\":\"Determining the optimum dose of remifentanil in combination with propofol for total intravenous anaesthesia in hysteroscopy under Narcotrend and SPI monitoring.\",\"authors\":\"Xiaoyu Zhang, Tao Xu, Xiaohu An, Jianwei Wang, Qiong Meng, Zifeng Xu\",\"doi\":\"10.1177/20420986241289204\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Outpatient hysteroscopic surgery requires patients to be anaesthetised and recover quickly, and the drugs used must be safe and effective. Remifentanil is typically co-administered with propofol as total intravenous anaesthesia (TIVA) for hysteroscopy because of its favourable pharmacokinetic and pharmacodynamic properties. However, the optimal dose of remifentanil when co-administered with propofol without neuromuscular blocking agents (NMBAs) has not been established.</p><p><strong>Objectives: </strong>In this sequential dose-finding study, the 90% effective dose (ED90) of remifentanil effect-site concentration (Ce) combined with propofol without NMBAs during outpatient hysteroscopy was calculated to minimise the side effects of using higher doses.</p><p><strong>Design: </strong>This sequential dose-finding study was conducted in August 2022.</p><p><strong>Methods: </strong>Forty patients who underwent outpatient hysteroscopy under TIVA were included in the study. With a biased coin up-and-down design, the initial remifentanil Ce was established at 2 ng/mL, and the subsequent remifentanil dosage was determined based on the reaction of the previous patient. The primary outcome was a remifentanil Ce that resulted in successful TIVA by maintaining a Narcotrend index < 60, surgical pleth index (SPI) < 50, and without patient movement throughout hysteroscopy. Secondary outcomes included rates of hypotension-related symptoms and interventions, drug consumption, post-anaesthesia care unit (PACU)-estimated visual analogue scale (VAS) and Ramsay sedation scores, modified Aldrete scores, and other adverse effects of anaesthesia. The ED90 and 95% confidence intervals (CI) were estimated using isotonic regression methods and bootstrapping.</p><p><strong>Results: </strong>For TIVA without NMBAs during outpatient hysteroscopy, the ED90 Ce of remifentanil combined with propofol was determined to be 2.75 ng/mL (95% CI, 2.50-3.00 ng/mL). The incidence of peri-operative adverse effects of anaesthesia was relatively low. All the patients had satisfactory VAS, Ramsay sedation, and modified Aldrete scores in the PACU.</p><p><strong>Conclusion: </strong>Remifentanil at a Ce of 2.75 ng/mL is recommended for TIVA combined with propofol in outpatient hysteroscopic surgery.</p><p><strong>Trial registration: </strong>http://www.chictr.org.cn (ChiCTR2200062284; 31/7/2022).</p>\",\"PeriodicalId\":23012,\"journal\":{\"name\":\"Therapeutic Advances in Drug Safety\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536375/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/20420986241289204\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20420986241289204","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

背景:门诊宫腔镜手术要求对患者进行麻醉并使其迅速恢复,而且所用药物必须安全有效。由于瑞芬太尼具有良好的药代动力学和药效学特性,因此在宫腔镜手术中通常与异丙酚联合使用作为全静脉麻醉(TIVA)。然而,在不使用神经肌肉阻滞剂(NMBA)的情况下,瑞芬太尼与异丙酚合用的最佳剂量尚未确定:在这项顺序剂量探索研究中,计算了在门诊宫腔镜手术中瑞芬太尼效应部位浓度(Ce)与不含神经肌肉阻断剂的异丙酚联合用药的90%有效剂量(ED90),以尽量减少使用较大剂量的副作用:方法:40名在门诊接受宫腔镜检查的患者:研究纳入了40名在TIVA下接受门诊宫腔镜检查的患者。采用偏置硬币上下设计,将初始瑞芬太尼Ce设定为2纳克/毫升,并根据前一位患者的反应确定后续的瑞芬太尼剂量。主要结果是瑞芬太尼Ce维持在Narcotrend指数结果的水平,从而导致TIVA成功:对于门诊宫腔镜手术中不使用 NMBAs 的 TIVA,瑞芬太尼与异丙酚联合使用的 ED90 Ce 被确定为 2.75 纳克/毫升(95% CI,2.50-3.00 纳克/毫升)。围手术期麻醉不良反应的发生率相对较低。所有患者在 PACU 的 VAS、Ramsay 镇静和改良 Aldrete 评分均令人满意:结论:推荐在门诊宫腔镜手术中使用Ce为2.75 ng/mL的雷米芬太尼联合异丙酚进行TIVA。试验注册:http://www.chictr.org.cn (ChiCTR2200062284; 31/7/2022)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Determining the optimum dose of remifentanil in combination with propofol for total intravenous anaesthesia in hysteroscopy under Narcotrend and SPI monitoring.

Background: Outpatient hysteroscopic surgery requires patients to be anaesthetised and recover quickly, and the drugs used must be safe and effective. Remifentanil is typically co-administered with propofol as total intravenous anaesthesia (TIVA) for hysteroscopy because of its favourable pharmacokinetic and pharmacodynamic properties. However, the optimal dose of remifentanil when co-administered with propofol without neuromuscular blocking agents (NMBAs) has not been established.

Objectives: In this sequential dose-finding study, the 90% effective dose (ED90) of remifentanil effect-site concentration (Ce) combined with propofol without NMBAs during outpatient hysteroscopy was calculated to minimise the side effects of using higher doses.

Design: This sequential dose-finding study was conducted in August 2022.

Methods: Forty patients who underwent outpatient hysteroscopy under TIVA were included in the study. With a biased coin up-and-down design, the initial remifentanil Ce was established at 2 ng/mL, and the subsequent remifentanil dosage was determined based on the reaction of the previous patient. The primary outcome was a remifentanil Ce that resulted in successful TIVA by maintaining a Narcotrend index < 60, surgical pleth index (SPI) < 50, and without patient movement throughout hysteroscopy. Secondary outcomes included rates of hypotension-related symptoms and interventions, drug consumption, post-anaesthesia care unit (PACU)-estimated visual analogue scale (VAS) and Ramsay sedation scores, modified Aldrete scores, and other adverse effects of anaesthesia. The ED90 and 95% confidence intervals (CI) were estimated using isotonic regression methods and bootstrapping.

Results: For TIVA without NMBAs during outpatient hysteroscopy, the ED90 Ce of remifentanil combined with propofol was determined to be 2.75 ng/mL (95% CI, 2.50-3.00 ng/mL). The incidence of peri-operative adverse effects of anaesthesia was relatively low. All the patients had satisfactory VAS, Ramsay sedation, and modified Aldrete scores in the PACU.

Conclusion: Remifentanil at a Ce of 2.75 ng/mL is recommended for TIVA combined with propofol in outpatient hysteroscopic surgery.

Trial registration: http://www.chictr.org.cn (ChiCTR2200062284; 31/7/2022).

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Therapeutic Advances in Drug Safety
Therapeutic Advances in Drug Safety Medicine-Pharmacology (medical)
CiteScore
6.70
自引率
4.50%
发文量
31
审稿时长
9 weeks
期刊介绍: Therapeutic Advances in Drug Safety delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in drug safety, providing a forum in print and online for publishing the highest quality articles in this area. The editors welcome articles of current interest on research across all areas of drug safety, including therapeutic drug monitoring, pharmacoepidemiology, adverse drug reactions, drug interactions, pharmacokinetics, pharmacovigilance, medication/prescribing errors, risk management, ethics and regulation.
期刊最新文献
Determining the optimum dose of remifentanil in combination with propofol for total intravenous anaesthesia in hysteroscopy under Narcotrend and SPI monitoring. The evolution of the Pharmacovigilance department in the pharmaceutical industry: results of an Italian national survey. Comparison of a single intravenous infusion of alfentanil or sufentanil combined with target-controlled infusion of propofol for daytime hysteroscopy: a randomized clinical trial. Governance of artificial intelligence and machine learning in pharmacovigilance: what works today and what more is needed? Patient-centric decision-making in supplements intake and disclosure in clinical practice: a novel SIDP-12 tool to prevent drug-supplement interaction.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1