A Multicenter, Randomized, Double-Blind, Positive-Controlled, Non-Inferiority, Phase III Clinical Trial Evaluating the Efficacy and Safety of Emulsified Isoflurane for Anesthesia Induction in Patients
机构:[1]Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu, Sichuan, Peoples R China四川大学华西医院[2]Sichuan Univ, West China Hosp, Natl Local Joint Engn Res Ctr Translat Med Anesth, Dept Anesthesiol,Lab Anaesthesia & Crit Care Med, Chengdu 610041, Sichuan, Peoples R China四川大学华西医院[3]Sichuan Univ, West China Hosp, Natl Local Joint Engn Res Ctr Translat Med Anesth, Chengdu, Sichuan, Peoples R China四川大学华西医院[4]Chancheng Dist Cent Hosp Foshan City, Dept Anesthesiol, Foshan, Fujian, Peoples R China[5]Cent South Univ, Dept Anesthesiol, Xiangya Hosp 3, Xiangya, Hunan, Peoples R China[6]Zunyi Med Coll, Dept Anesthesiol, Affiliated Hosp, Zunyi, Guizhou, Peoples R China[7]Chongqing Univ, Dept Anesthesiol, Fuling Hosp, Chongqing, Peoples R China[8]Guangdong Prov Hosp Tradit Chinese Med, Dept Anesthesiol, Guangzhou, Guangdong, Peoples R China大德路总院麻醉科大德路总院麻醉科广东省中医院[9]Univ City Branch, Guangdong Hosp Tradit Chinese Med, Dept Anesthesiol, Guangzhou, Guangdong, Peoples R China大德路总院麻醉科大德路总院麻醉科广东省中医院[10]FuJian Med Univ, Dept Anesthesiol, Zhangzhou Affiliated Hosp, Zhangzhou, Fujian, Peoples R China[11]Yichang Cent Peoples Hosp, Dept Anesthesiol, Yichang, Hubei, Peoples R China[12]Nanchang Univ, Dept Anesthesiol, Affiliated Hosp 2, Nanchang, Jiangxi, Peoples R China[13]Wenzhou Med Univ, Dept Anesthesiol, Affiliated Hosp 2, Wenzhou, Zhejiang, Peoples R China[14]Xi An Jiao Tong Univ, Dept Anesthesiol, Affiliated Hosp 1, Xian, Shanxi, Peoples R China[15]Humanwell Healthcare Grp Co Ltd, Yichang, Hubei, Peoples R China
Background Emulsified isoflurane was designed to circumvent the deficiencies of inhalation anesthetics, which have a longer time to onset, result in a higher drug consumption, and for which a specific anesthesia machine is required for clinical use. The aim of this study was to compare the efficacy and safety of emulsified isoflurane with propofol for anesthesia induction in adults patients. Methods This multicenter, randomized, double-blind, positive-controlled, non-inferiority, phase III clinical trial compared the efficacy and safety of emulsified isoflurane with propofol for anesthesia induction. Each patient in the emulsified isoflurane group received a single bolus injection of 12% emulsified isoflurane at a dose of 30 mg/kg, and each patient in the propofol group received a single bolus injection of 0.8% propofol at a dose of 2 mg/kg. The primary outcome of the efficacy evaluation was the proportion of participants with successful anesthesia induction, which was regarded as a Modified Observer's Assessment of Alertness/Sedation (MOANS) score of < 1 and lack of use of other sedative drugs. A number of secondary efficacy outcomes were also assessed. Safety was monitored based on (1) adverse events, (2) repeated measurement of vital signs; (3) physical examination, (4) routine laboratory examinations of hematology, biochemistry, urine, coagulation function, and (5) 12-lead electrocardiogram. Results A total of 416 patients were enrolled (n = 208 in each group) and 398 patients were administered study drug. The proportion of participants with successful anesthesia induction was 100% with a 95% confidence interval of - 1.9% to + 1.9% for the emulsified isoflurane and propofol groups, which met the predesigned non-inferiority criteria of 5%. The study demonstrated the non-inferiority of sedation produced by emulsified isoflurane compared to propofol. Among the secondary efficacy outcomes, emulsified isoflurane showed a better cardiovascular stability than propofol. The number of patients from the emulsified isoflurane group who experienced drug-related adverse events was significantly higher than that of patients from the propofol group. However, there was no significant difference between the two groups in terms of adverse events or drug-related adverse events of grades 3-5. Conclusions Emulsified isoflurane exhibited non-inferiority of anesthesia/sedation compared to propofol in patients undergoing anesthesia induction.
第一作者机构:[1]Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu, Sichuan, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu, Sichuan, Peoples R China[2]Sichuan Univ, West China Hosp, Natl Local Joint Engn Res Ctr Translat Med Anesth, Dept Anesthesiol,Lab Anaesthesia & Crit Care Med, Chengdu 610041, Sichuan, Peoples R China[3]Sichuan Univ, West China Hosp, Natl Local Joint Engn Res Ctr Translat Med Anesth, Chengdu, Sichuan, Peoples R China
推荐引用方式(GB/T 7714):
Yang Hui,Zhang YuJun,Liu ChuiLiang,et al.A Multicenter, Randomized, Double-Blind, Positive-Controlled, Non-Inferiority, Phase III Clinical Trial Evaluating the Efficacy and Safety of Emulsified Isoflurane for Anesthesia Induction in Patients[J].CNS DRUGS.2022,36(12):1301-1311.doi:10.1007/s40263-022-00970-w.
APA:
Yang, Hui,Zhang, YuJun,Liu, ChuiLiang,Ou, YangWen,Zhu, YuHang...&Zhang, WenSheng.(2022).A Multicenter, Randomized, Double-Blind, Positive-Controlled, Non-Inferiority, Phase III Clinical Trial Evaluating the Efficacy and Safety of Emulsified Isoflurane for Anesthesia Induction in Patients.CNS DRUGS,36,(12)
MLA:
Yang, Hui,et al."A Multicenter, Randomized, Double-Blind, Positive-Controlled, Non-Inferiority, Phase III Clinical Trial Evaluating the Efficacy and Safety of Emulsified Isoflurane for Anesthesia Induction in Patients".CNS DRUGS 36..12(2022):1301-1311