Hemantkumar Indrani, Swain Ashok Kumar, Mishra Manjaree, Singh Swati, Gurudatt Challakere Lakshminarain, Giridhar Janampet Bekkam
Department of Anaesthesia, Seth GS Medical College and KEM Hospital, Parel East, Mumbai, Maharashtra, India.
Medical Services, Themis Medicare Limited, Goregaon West, Mumbai, Maharashtra, India.
Indian J Anaesth. 2024 Nov;68(11):985-995. doi: 10.4103/ija.ija_289_24. Epub 2024 Oct 26.
Remifentanil and fentanyl are potent opioid analgesics commonly used during surgery due to their distinct pharmacological profiles. This study aimed to compare the efficacy and safety of a generic remifentanil (test drug) with fentanyl and Ultiva (innovator formulation) during general anaesthesia in the Indian population.
This phase III, multi-centre (n = 13), randomised, three-arm, comparative study was conducted from 24 November 2021 to 31 March 2022. Eligible subjects scheduled for elective therapeutic and diagnostic surgical procedures (n = 314) were randomised into generic remifentanil, Ultiva, and fentanyl groups. An independent anaesthetist blinded to treatment allocation assessed efficacy and safety parameters. The primary efficacy endpoint was haemodynamic response during specific activities (endotracheal intubation, skin incision, skin closure, and extubation).
The study groups exhibited no significant differences in demographic and baseline characteristics. Heart rate was similar between the remifentanil and Ultiva groups measured during laryngeal intubation, skin incision, skin closure, and extubation ( > 0.05 in all four procedures). Heart rate was significantly higher in the fentanyl group in comparison to the remifentanil group during laryngeal intubation ( = 0.035), skin incision ( = 0.017), skin closure ( = 0.001), and extubation ( = 0.026). The need for vasopressor and anti-cholinergic drugs was similar between groups, and no subject required naloxone administration.
Our study's findings demonstrated that generic remifentanil is non-inferior to fentanyl and equivalent to Ultiva for general anaesthesia in Indian patients undergoing various surgical and diagnostic procedures. Remifentanil offers advantages in terms of optimum haemodynamic stability, fast equilibrating analgesia, and rapid emergence from sedation, making it a suitable alternative to fentanyl.
瑞芬太尼和芬太尼是强效阿片类镇痛药，因其独特的药理学特性，常用于手术过程中。本研究旨在比较印度人群全身麻醉期间，仿制瑞芬太尼（受试药物）与芬太尼及优帝尔（创新制剂）的疗效和安全性。
本III期多中心（n = 13）随机三臂对照研究于2021年11月24日至2022年3月31日进行。计划接受择期治疗性和诊断性外科手术的符合条件的受试者（n = 314）被随机分为仿制瑞芬太尼组、优帝尔组和芬太尼组。一名对治疗分配不知情的独立麻醉师评估疗效和安全性参数。主要疗效终点是特定活动（气管插管、皮肤切开、皮肤缝合和拔管）期间的血流动力学反应。
研究组在人口统计学和基线特征方面无显著差异。在喉镜插管、皮肤切开、皮肤缝合和拔管期间测量，瑞芬太尼组和优帝尔组的心率相似（所有四项操作中P>0.05）。在喉镜插管（P = 0.035）、皮肤切开（P = 0.017）、皮肤缝合（P = 0.001）和拔管（P = 0.026）期间，芬太尼组的心率显著高于瑞芬太尼组。各组对血管加压药和抗胆碱能药物的需求相似，且无受试者需要使用纳洛酮。
我们研究的结果表明，对于接受各种外科和诊断手术的印度患者，全身麻醉时仿制瑞芬太尼不劣于芬太尼，且与优帝尔相当。瑞芬太尼在最佳血流动力学稳定性、快速平衡镇痛和快速苏醒方面具有优势，使其成为芬太尼的合适替代品。
