The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial
单位：[1]1Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China[2]2Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China临床科室麻醉科麻醉科首都医科大学附属北京友谊医院[3]3Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China北京朝阳医院[4]4Department of Anesthesiology, Yijishan Hospital of Wannan Medical College, Wuhu 241001, Anhui, China[5]5Department of Anesthesiology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, Shanxi, China[6]6Department of Anesthesiology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shanxi, China[7]7Department of Anesthesiology, Guangdong Provincial People’s Hospital, Guangzhou 510080, Guangdong, China[8]8Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, Guangdong, China中山大学附属第二医院[9]9Department of Anesthesiology, General Hospital of Tianjin Medical University, Tianjin 300052, China[10]10Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266011, Shandong, China[11]11Department of Anesthesiology, Tongji Medical College, Huazhong University of Sciences Technology, Wuhan 430030, Hubei, China[12]12Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400042, China重庆医科大学附属第一医院[13]13Department of Anesthesiology, General Hospital of Shenyang Military Region, PLA, Shenyang 110000, Liaoning, China[14]14Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang 550000, Guizhou, China[15]15Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China四川大学华西医院[16]16Department of Anesthesiology, Anhui Provincial Hospital, Hefei 230001, Anhui, China[17]17Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University, Xi’an 710038, Shanxi, China[18]18Department of Anesthesiology, The First People’s Hospital of Lianyungang, Lianyungang 222061, Jiangsu, China[19]19Department of Anesthesiology, Henan Provincial People’s Hospital, Zhengzhou 450003, Henan, China
This study aimed to evaluate the efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy. In this multicentered, blinded, randomized, active-controlled, non-inferior phase III trial, 384 eligible patients who were about to undergo colonoscopy were randomized as a ratio of 1:1 into remimazolam and propofol group. Procedure success was assessed and defined as the completion of colonoscopy without administration of rescue sedative agent or more than 5 top-ups of trial drug in any 15 minute-period after initial administration of trial drug. Sedation quality was evaluated by Modified Observer's Assessment of Alertness/Sedation score. Treatment-emergent adverse events were recorded. Procedure success rate was 96.91% (188/194) in remimazolam group and 100% (190/190) in propofol group, and the difference in rate was -3.09% with 95% confidence interval (CI) of -5.53%similar to-0.66%. Since the lower limit of 95% CI was greater than the non-inferiority margin of -8.00%, the efficacy of remimazolam tosylate was non-inferior to propofol. Besides, induction time of sedation was increased (P<0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert (P>0.05) or time to discharge (P>0.05) were unchanged. For safety assessment, total treatment-emergent adverse events were decreased in remimazolam group compared to propofol group (P<0.001); specifically, administration site pain (P<0.001), increased bilirubin (P=0.019), decreased respiratory rate (P<0.001) and decreased SpO(2) (P<0.001) were less frequent in remimazolam group compared with propofol group. In conclusion, remimazolam tosylate is non-inferior in sedation efficacy while safer than propofol in patients undergoing colonoscopy.
第一作者单位：[1]1Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
通讯作者：
通讯机构：[1]1Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China[*1]Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 1 Shuaifu Yuan, Beijing 100730, China.
推荐引用方式(GB/T 7714)：
Chen Shaohui,Wang Jin,Xu Xiaohan,et al.The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial[J].AMERICAN JOURNAL of TRANSLATIONAL RESEARCH.2020,12(8):4594-4603.
APA：
Chen Shaohui,Wang Jin,Xu Xiaohan,Huang Yuguang,Xue Shanfu...&Zhang Jiaqiang.(2020).The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial.AMERICAN JOURNAL of TRANSLATIONAL RESEARCH,12,(8)
MLA：
Chen Shaohui,et al."The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial".AMERICAN JOURNAL of TRANSLATIONAL RESEARCH 12..8(2020):4594-4603
