Modified Dixon sequential method to determine the effective dose of alfentanil compounded with propofol for day-case hysteroscopy.

IF 3.4 3区 医学 Q2 PHARMACOLOGY & PHARMACY Therapeutic Advances in Drug Safety Pub Date : 2023-12-06 eCollection Date: 2023-01-01 DOI:10.1177/20420986231214992
Chenyang Xu, Rui Peng, Xiali Qian, Shanwu Feng, Hongmei Yuan
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Abstract

Background: Propofol combined with alfentanil is suitable for intravenous anesthesia for day-case hysteroscopy.

Objective: To investigate the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil compounded with propofol for day-case hysteroscopy.

Design: In all, 29 patients who volunteered for painless hysteroscopy in 2022 were recruited. 1.5 mg/kg propofol was given as a sedative to all patients. The trial was conducted using the modified Dixon sequential method, with an initial dose of 10 μg/kg of alfentanil, and the subject's alfentanil dose depended on whether the prior hysteroscopy had failed, which was defined as inadequate cervical dilatation and hysteroscope placement with the patient exhibiting body movement, frowning, or a MOAA/S score >1. If the hysteroscopy failed (i.e. a positive response), the subsequent subject's alfentanil dosage was raised, and conversely (i.e. a negative response), the dose was decreased, with the adjacent dose ratio always being 1:1.2. The formal test begins with the first crossover wave and lasts until seven crossover waves materialize.

Methods: The probit method was used to calculate the ED50, ED95, and corresponding 95% confidence intervals (CIs) of alfentanil compounded with propofol for hysteroscopy.

Results: The ED50 and ED95 of alfentanil combined with propofol for day-case hysteroscopy were 5.701 (95% CI: 3.841-7.069) μg/kg and 8.817 (95% CI: 7.307-20.868) μg/kg, respectively.

Conclusion: Alfentanil at 8.817 μg/kg in conjunction with propofol is a successful and safe approach for day-case painless hysteroscopy.

Trial registration: The trial registry name: Modified sequential method to determine the half-effective dose of alfentanil compounded with propofol for ambulatory hysteroscopy. The URL of registration is https://www.chictr.org.cn/showproj.html?proj=171786, where the full trial protocol can be accessed. Registration number: ChiCTR2200061619.

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修改后的迪克森序列法,用于确定日间宫腔镜检查中阿芬太尼与异丙酚复合的有效剂量。
背景:丙泊酚联合阿芬太尼适用于日间宫腔镜检查的静脉麻醉:丙泊酚联合阿芬太尼适用于日间宫腔镜检查的静脉麻醉:研究阿芬太尼与丙泊酚复合用于日间宫腔镜检查的中位有效剂量(ED50)和95%有效剂量(ED95):设计:共招募了29名自愿在2022年接受无痛宫腔镜检查的患者。所有患者均使用 1.5 毫克/千克异丙酚作为镇静剂。试验采用改良的迪克森序列法,初始剂量为10微克/千克阿芬太尼,受试者的阿芬太尼剂量取决于之前的宫腔镜检查是否失败,宫腔镜检查失败的定义是宫颈扩张和宫腔镜置入不充分,患者表现出身体移动、皱眉或MOAA/S评分>1。如果宫腔镜检查失败(即阳性反应),则增加后续受试者的阿芬太尼剂量,反之(即阴性反应),则减少剂量,相邻剂量比始终为 1:1.2。正式测试从第一个交叉波开始,直到出现七个交叉波为止:采用 probit 法计算阿芬太尼与异丙酚复方用于宫腔镜检查的 ED50、ED95 以及相应的 95% 置信区间 (CI):结果:阿芬太尼与异丙酚复方用于日间宫腔镜检查的 ED50 和 ED95 分别为 5.701 (95% CI: 3.841-7.069) μg/kg 和 8.817 (95% CI: 7.307-20.868) μg/kg:试验登记:试验登记名称:确定阿芬太尼与异丙酚复合用于非住院宫腔镜检查的半有效剂量的改良顺序法。注册网址:https://www.chictr.org.cn/showproj.html?proj=171786,可在此查阅完整的试验方案。注册号ChiCTR2200061619。
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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.
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