Age-Specific Plasma Concentration, Efficacy and Safety of Ciprofol (Cipepofol) for Induction and Maintenance of General Anesthesia in Pediatric Patients Undergoing Elective Surgery: A Single-Arm Prospective, Pragmatic Trial.

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Clinical Drug Investigation Pub Date : 2025-03-01 Epub Date: 2025-02-17 DOI:10.1007/s40261-025-01425-y
Zheng Chen, Tuochao Peng, Shuibing Zhang, Qiaoyun Yang, Shuangquan Qu, Yong Cao, Junxia Chen, Yiwei Mao
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引用次数: 0

Abstract

Background and objective: Ciprofol (Cipepofol) currently has well-established clinical research data in adult Chinese patients, but there is a lack of reliable research data in pediatric patients. This study aimed to assess the age-specific plasma concentration, efficacy and safety profiles of cipepofol in pediatric patients aged 2-17 years during the induction and maintenance of general anesthesia.

Methods: This was a single-arm, open-label, prospective, pragmatic study conducted in the Hunan Children's Hospital from May 10, 2023 to August 25, 2023, that involved pediatric patients undergoing elective surgery after the induction and maintenance of general anesthesia. Cipepofol was administered as an intravenous bolus injection of 0.6 mg/kg (patients aged 2-11 years) or 0.5 mg/kg (12-17 years) for induction, followed by an initial maintenance infusion of 1.2 mg/kg/h or 1.4 mg/kg/h, respectively. The primary endpoint-plasma concentration of cipepofol was measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. The age-specific plasma concentration, efficacy and safety profiles of cipepofol are summarized using descriptive statistics.

Results: All 38 enrolled patients completed the study, including 14 children aged 2-5 years, 12 children aged 6-11 years and 12 children aged 12-17 years. The trends of plasma concentration variations among patients in the three age groups were largely consistent. The success rates of anesthesia induction and maintenance for patients in the three groups were both 100%, and no patients required rescue medication. Children aged 2 to 5 years had the longest median durations of successful anesthetic induction (1.1 min) and eyelash reflection disappearance (1.2 min), while the median durations for patients aged 6-11 years and those aged 12-17 years (0.5 and 0.5 min) were similar. The median time to extubation and length of stay in the post-anesthesia care unit tended to be the longest in children aged 6-11 years (23.5 and 30.0 min) but were comparable for those aged 2-5 years (10.5 min and 20.0 min) and 12-17 years (11.0 and 20.0 min). The median time to full alertness tended to decrease with increasing age (33.7 vs 25.8 vs 22.7 min). A total of 4 (10.5%) patients experienced treatment-emergent adverse events in those aged 2-5 years or 12-17 years, with a severity of grade 1 or grade 2.

Conclusion: Cipepofol had good safety for the induction and maintenance of general anesthesia in pediatric patients aged over 2 years. The dosing regimen with an intravenous bolus injection of 0.5 mg/kg for induction, followed by an initial maintenance infusion of 1.4 mg/kg/h was adequate for children aged 12-17 years; age-specific dose regimen for children aged 2-11 years should be improved by further large-scale prospective studies.

Trial registration: ChiCTR2400085640, July 14, 2024, retrospectively registered.

一项单臂前瞻性实用试验:环丙酚(Cipepofol)用于择期手术儿童患者诱导和维持全身麻醉的年龄特异性血浆浓度、疗效和安全性
背景与目的:环丙酚(Cipepofol)目前在中国成人患者中有完善的临床研究数据,但在儿科患者中缺乏可靠的研究数据。本研究旨在评估2-17岁儿童患者在诱导和维持全身麻醉时的年龄特异性血药浓度、疗效和安全性。方法:这是一项于2023年5月10日至2023年8月25日在湖南省儿童医院开展的单臂、开放标签、前瞻性、实用性研究,研究对象为全麻诱导和维持后择期手术的儿童患者。Cipepofol以0.6 mg/kg(2-11岁患者)或0.5 mg/kg(12-17岁患者)静脉注射的方式进行诱导,随后分别以1.2 mg/kg/h或1.4 mg/kg/h的初始维持输注。采用高效液相色谱-串联质谱(HPLC-MS/MS)方法测定主要终点血药浓度。使用描述性统计总结了西泊酚的年龄特异性血药浓度、疗效和安全性。结果:38例入组患者全部完成研究,包括14例2-5岁儿童、12例6-11岁儿童和12例12-17岁儿童。三个年龄组患者血浆浓度变化趋势基本一致。三组患者麻醉诱导和维持成功率均为100%,无患者需要抢救用药。2 ~ 5岁患儿麻醉诱导成功的中位持续时间最长(1.1 min),睫毛反射消失的中位持续时间最长(1.2 min), 6 ~ 11岁患儿和12 ~ 17岁患儿的中位持续时间相似(0.5 min和0.5 min)。6-11岁儿童拔管的中位时间和麻醉后护理病房的住院时间最长(23.5 min和30.0 min),但2-5岁(10.5 min和20.0 min)和12-17岁(11.0和20.0 min)的中位时间和麻醉后护理单元的中位时间相当。达到完全清醒的中位时间随着年龄的增加而减少(33.7 min vs 25.8 min vs 22.7 min)。在2-5岁或12-17岁的患者中,共有4例(10.5%)患者经历了治疗后出现的不良事件,严重程度为1级或2级。结论:西泊酚用于2岁以上儿童全麻诱导和维持具有良好的安全性。对于12-17岁的儿童,诱导时静脉滴注0.5 mg/kg,随后初始维持输注1.4 mg/kg/h的给药方案是足够的;2-11岁儿童的年龄特异性给药方案应通过进一步的大规模前瞻性研究加以改进。试验注册:ChiCTR2400085640, 2024年7月14日,回顾性注册。
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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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