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

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...

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Published in:	American journal of translational research Vol. 12; no. 8; pp. 4594 - 4603
Main Authors:	Chen, Shaohui, Wang, Jin, Xu, Xiaohan, Huang, Yuguang, Xue, Shanfu, Wu, Anshi, Jin, Xiaoju, Wang, Qiang, Lyu, Jianrui, Wang, Sheng, Li, Yujuan, Yu, Yonghao, Ai, Dengbin, Luo, Ailin, Min, Su, Li, Lin, Zou, Xiaohua, Liu, Jin, Lv, Peilin, Chai, Xiaoqin, Sun, Xude, Zhao, Zhibin, Zhang, Jiaqiang
Format:	Journal Article
Language:	English
Published:	e-Century Publishing Corporation 01-01-2020
Subjects:	Original
Online Access:	Get full text
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Summary:	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%~-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.
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ISSN:	1943-8141 1943-8141