The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial

被引：78

作者：

Chen, Shaohui ^{[1
]}

Wang, Jin ^{[1
]}

Xu, Xiaohan ^{[1
]}

Huang, Yuguang ^{[1
]}

Xue, Shanfu ^{[2
]}

Wu, Anshi ^{[3
]}

Jin, Xiaoju ^{[4
]}

Wang, Qiang ^{[5
]}

Lyu, Jianrui ^{[6
]}

Wang, Sheng ^{[7
]}

Li, Yujuan ^{[8
]}

Yu, Yonghao ^{[9
]}

Ai, Dengbin ^{[10
]}

Luo, Ailin ^{[11
]}

Min, Su ^{[12
]}

Li, Lin ^{[13
]}

Zou, Xiaohua ^{[14
]}

Liu, Jin ^{[15
]}

Lv, Peilin ^{[15
]}

Chai, Xiaoqin ^{[16
]}

Sun, Xude ^{[17
]}

Zhao, Zhibin ^{[18
]}

Zhang, Jiaqiang ^{[19
]}

机构：

[1] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Anesthesiol, 1 Shuaifu Yuan, Beijing 100730, Peoples R China

[2] Capital Med Univ, Dept Anesthesiol, Beijing Friendship Hosp, Beijing 100050, Peoples R China

[3] Capital Med Univ, Beijing Chaoyang Hosp, Dept Anesthesiol, Beijing 100020, Peoples R China

[4] Yijishan Hosp, Dept Anesthesiol, Wannan Med Coll, Wuhu 241001, Anhui, Peoples R China

[5] Xi An Jiao Tong Univ, Dept Anesthesiol, Affiliated Hosp 1, Xian 710061, Shanxi, Peoples R China

[6] Xi An Jiao Tong Univ, Dept Anesthesiol, Affiliated Hosp 1, Xian 710004, Shanxi, Peoples R China

[7] Guangdong Prov Peoples Hosp, Dept Anesthesiol, Guangzhou 510080, Guangdong, Peoples R China

[8] Sun Yat Sen Univ, Dept Anesthesiol, Sun Yat Sen Mem Hosp, Guangzhou 510120, Guangdong, Peoples R China

[9] Tianjin Med Univ, Dept Anesthesiol, Gen Hosp, Tianjin 300052, Peoples R China

[10] Qingdao Municipal Hosp, Dept Anesthesiol, Qingdao 266011, Shandong, Peoples R China

[11] Huazhong Univ Sci Technol, Tongji Med Coll, Dept Anesthesiol, Wuhan 430030, Hubei, Peoples R China

[12] Chongqing Med Univ, Dept Anesthesiol, Affiliated Hosp 1, Chongqing, Peoples R China

[13] PLA, Gen Hosp Shenyang Mil Reg, Dept Anesthesiol, Shenyang 110000, Liaoning, Peoples R China

[14] Guizhou Med Univ, Dept Anesthesiol, Affiliated Hosp, Guiyang 550000, Guizhou, Peoples R China

[15] Sichuan Univ, West China Hosp, Dept Anesthesiol, Chengdu 610041, Sichuan, Peoples R China

[16] Anhui Prov Hosp, Dept Anesthesiol, Hefei 230001, Anhui, Peoples R China

[17] Fourth Mil Med Univ, Tangdu Hosp, Dept Anesthesiol, Xian 710038, Shanxi, Peoples R China

[18] First Peoples Hosp Lianyungang, Dept Anesthesiol, Lianyungang 222061, Jiangsu, Peoples R China

[19] Henan Prov Peoples Hosp, Dept Anesthesiol, Zhengzhou 450003, Henan, Peoples R China

来源：

AMERICAN JOURNAL OF TRANSLATIONAL RESEARCH | 2020年 / 12卷 / 08期

关键词：

Remimazolam tosylate; propofol; colonoscopy; efficacy; treatment-emergent adverse events; CNS; 7056; SEDATION; MIDAZOLAM; PHARMACODYNAMICS; PHARMACOKINETICS; PLACEBO; CNS-7056;

D O I：

暂无

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：4594 / 4603

页数：10

共 15 条

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