Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non‐inferiority, phase III trial

Background and Aim Remimazolam tosilate (RT) is a new short‐acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. Methods This...

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Veröffentlicht in:Journal of gastroenterology and hepatology 2021-02, Vol.36 (2), p.474-481
Hauptverfasser: Chen, Shao‐Hui, Yuan, Tang‐Mi, Zhang, Jiao, Bai, Hua, Tian, Ming, Pan, Chu‐Xiong, Bao, Hong‐Guang, Jin, Xiao‐Ju, Ji, Fu‐Hai, Zhong, Tai‐Di, Wang, Qiang, Lv, Jian‐Rui, Wang, Sheng, Li, Yu‐Juan, Yu, Yong‐Hao, Luo, Ai‐Lin, Li, Xiang‐Kui, Min, Su, Li, Lin, Zou, Xiao‐Hua, Huang, Yu‐Guang
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container_issue 2
container_start_page 474
container_title Journal of gastroenterology and hepatology
container_volume 36
creator Chen, Shao‐Hui
Yuan, Tang‐Mi
Zhang, Jiao
Bai, Hua
Tian, Ming
Pan, Chu‐Xiong
Bao, Hong‐Guang
Jin, Xiao‐Ju
Ji, Fu‐Hai
Zhong, Tai‐Di
Wang, Qiang
Lv, Jian‐Rui
Wang, Sheng
Li, Yu‐Juan
Yu, Yong‐Hao
Luo, Ai‐Lin
Li, Xiang‐Kui
Min, Su
Li, Lin
Zou, Xiao‐Hua
Huang, Yu‐Guang
description Background and Aim Remimazolam tosilate (RT) is a new short‐acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. Methods This positive‐controlled, non‐inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. Results The success rate of sedation in the RT group was non‐inferior to that in the propofol group (97.34% vs 100.00%; difference in rate −2.66%, 95% CI −4.96 to −0.36, meeting criteria for non‐inferiority). Patients in the RT group had longer time to adequate sedation (P 
doi_str_mv 10.1111/jgh.15188
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Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. Methods This positive‐controlled, non‐inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. Results The success rate of sedation in the RT group was non‐inferior to that in the propofol group (97.34% vs 100.00%; difference in rate −2.66%, 95% CI −4.96 to −0.36, meeting criteria for non‐inferiority). Patients in the RT group had longer time to adequate sedation (P &lt; 0.0001) but shorter time to fully alert (P &lt; 0.0001) than that in the propofol group. The incidences of hypotension (13.04% vs 42.86%, P &lt; 0.0001), treatment‐related hypotension (0.54% vs 5.82%, P &lt; 0.0001), and respiratory depression (1.09% vs 6.88%, P = 0.0064) were significantly lower in the RT group. AEs were reported in 74 (39.15%) patients in the RT group and 114 (60.32%) patients in the propofol group, with significant difference (P &lt; 0.0001). Conclusion This trial established non‐inferior sedation success rate of RT compared with propofol. RT allows faster recovery from sedation compared with propofol. The safety profile is favorable and appears to be superior to propofol, indicating that it was feasible and well tolerated for patients.</description><identifier>ISSN: 0815-9319</identifier><identifier>EISSN: 1440-1746</identifier><identifier>DOI: 10.1111/jgh.15188</identifier><identifier>PMID: 32677707</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>Adverse events ; Anesthesia ; benzodiazepine ; endoscopic sedation ; Endoscopy ; GABA (A) receptor agonist ; Hypotension ; Propofol ; remimazolam ; remimazolam tosilate ; Safety ; Success ; upper gastrointestinal endoscopy ; γ-Aminobutyric acid</subject><ispartof>Journal of gastroenterology and hepatology, 2021-02, Vol.36 (2), p.474-481</ispartof><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd</rights><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd.</rights><rights>2021 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4548-7c6cc762831e1d73e0816c7afa8b849323320ce827d8c36033fad6d1a48b02ac3</citedby><cites>FETCH-LOGICAL-c4548-7c6cc762831e1d73e0816c7afa8b849323320ce827d8c36033fad6d1a48b02ac3</cites><orcidid>0000-0002-6157-2198</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjgh.15188$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjgh.15188$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32677707$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Shao‐Hui</creatorcontrib><creatorcontrib>Yuan, Tang‐Mi</creatorcontrib><creatorcontrib>Zhang, Jiao</creatorcontrib><creatorcontrib>Bai, Hua</creatorcontrib><creatorcontrib>Tian, Ming</creatorcontrib><creatorcontrib>Pan, Chu‐Xiong</creatorcontrib><creatorcontrib>Bao, Hong‐Guang</creatorcontrib><creatorcontrib>Jin, Xiao‐Ju</creatorcontrib><creatorcontrib>Ji, Fu‐Hai</creatorcontrib><creatorcontrib>Zhong, Tai‐Di</creatorcontrib><creatorcontrib>Wang, Qiang</creatorcontrib><creatorcontrib>Lv, Jian‐Rui</creatorcontrib><creatorcontrib>Wang, Sheng</creatorcontrib><creatorcontrib>Li, Yu‐Juan</creatorcontrib><creatorcontrib>Yu, Yong‐Hao</creatorcontrib><creatorcontrib>Luo, Ai‐Lin</creatorcontrib><creatorcontrib>Li, Xiang‐Kui</creatorcontrib><creatorcontrib>Min, Su</creatorcontrib><creatorcontrib>Li, Lin</creatorcontrib><creatorcontrib>Zou, Xiao‐Hua</creatorcontrib><creatorcontrib>Huang, Yu‐Guang</creatorcontrib><title>Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non‐inferiority, phase III trial</title><title>Journal of gastroenterology and hepatology</title><addtitle>J Gastroenterol Hepatol</addtitle><description>Background and Aim Remimazolam tosilate (RT) is a new short‐acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. Methods This positive‐controlled, non‐inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. Results The success rate of sedation in the RT group was non‐inferior to that in the propofol group (97.34% vs 100.00%; difference in rate −2.66%, 95% CI −4.96 to −0.36, meeting criteria for non‐inferiority). Patients in the RT group had longer time to adequate sedation (P &lt; 0.0001) but shorter time to fully alert (P &lt; 0.0001) than that in the propofol group. The incidences of hypotension (13.04% vs 42.86%, P &lt; 0.0001), treatment‐related hypotension (0.54% vs 5.82%, P &lt; 0.0001), and respiratory depression (1.09% vs 6.88%, P = 0.0064) were significantly lower in the RT group. AEs were reported in 74 (39.15%) patients in the RT group and 114 (60.32%) patients in the propofol group, with significant difference (P &lt; 0.0001). Conclusion This trial established non‐inferior sedation success rate of RT compared with propofol. RT allows faster recovery from sedation compared with propofol. The safety profile is favorable and appears to be superior to propofol, indicating that it was feasible and well tolerated for patients.</description><subject>Adverse events</subject><subject>Anesthesia</subject><subject>benzodiazepine</subject><subject>endoscopic sedation</subject><subject>Endoscopy</subject><subject>GABA (A) receptor agonist</subject><subject>Hypotension</subject><subject>Propofol</subject><subject>remimazolam</subject><subject>remimazolam tosilate</subject><subject>Safety</subject><subject>Success</subject><subject>upper gastrointestinal endoscopy</subject><subject>γ-Aminobutyric acid</subject><issn>0815-9319</issn><issn>1440-1746</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kc1O3DAUha2qVRmmXfQFkKVuQJqA_xI77EaIwlRISFW7jjzOzYxHThzsRKNh1UfoM_IkNQywQOJu7uJ-OlfnHIS-UXJK05xtVutTmlOlPqAJFYJkVIriI5oQRfOs5LQ8QIcxbgghgsj8MzrgrJBSEjlB21_Q2lbfe6dbPPhonR4A2w6PfQ8Br3QcgrfdAHGwnXYYutpH4_vdOZ7jdnSDNZCuYYaDTqfW3kM9w53vHv7-s10Dwfpgh90M92sdAS8WCzwEq90X9KnRLsLX5z1Ff35c_r64zm5urxYX85vMiFyoTJrCGFkwxSnQWnJIlgojdaPVUomSM84ZMaCYrJXhBeG80XVRUy3UkjBt-BQd73X74O_G5KJqbTTgnO7Aj7FigomyLBXLE_r9DbrxY0imH6mS5WWep3dTdLKnTPAxBmiqPqQAw66ipHpso0ptVE9tJPboWXFctlC_ki_xJ-BsD2ytg937StXPq-u95H_gLZVq</recordid><startdate>202102</startdate><enddate>202102</enddate><creator>Chen, Shao‐Hui</creator><creator>Yuan, Tang‐Mi</creator><creator>Zhang, Jiao</creator><creator>Bai, Hua</creator><creator>Tian, Ming</creator><creator>Pan, Chu‐Xiong</creator><creator>Bao, Hong‐Guang</creator><creator>Jin, Xiao‐Ju</creator><creator>Ji, Fu‐Hai</creator><creator>Zhong, Tai‐Di</creator><creator>Wang, Qiang</creator><creator>Lv, Jian‐Rui</creator><creator>Wang, Sheng</creator><creator>Li, Yu‐Juan</creator><creator>Yu, Yong‐Hao</creator><creator>Luo, Ai‐Lin</creator><creator>Li, Xiang‐Kui</creator><creator>Min, Su</creator><creator>Li, Lin</creator><creator>Zou, Xiao‐Hua</creator><creator>Huang, Yu‐Guang</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6157-2198</orcidid></search><sort><creationdate>202102</creationdate><title>Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non‐inferiority, phase III trial</title><author>Chen, Shao‐Hui ; Yuan, Tang‐Mi ; Zhang, Jiao ; Bai, Hua ; Tian, Ming ; Pan, Chu‐Xiong ; Bao, Hong‐Guang ; Jin, Xiao‐Ju ; Ji, Fu‐Hai ; Zhong, Tai‐Di ; Wang, Qiang ; Lv, Jian‐Rui ; Wang, Sheng ; Li, Yu‐Juan ; Yu, Yong‐Hao ; Luo, Ai‐Lin ; Li, Xiang‐Kui ; Min, Su ; Li, Lin ; Zou, Xiao‐Hua ; Huang, Yu‐Guang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4548-7c6cc762831e1d73e0816c7afa8b849323320ce827d8c36033fad6d1a48b02ac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Anesthesia</topic><topic>benzodiazepine</topic><topic>endoscopic sedation</topic><topic>Endoscopy</topic><topic>GABA (A) receptor agonist</topic><topic>Hypotension</topic><topic>Propofol</topic><topic>remimazolam</topic><topic>remimazolam tosilate</topic><topic>Safety</topic><topic>Success</topic><topic>upper gastrointestinal endoscopy</topic><topic>γ-Aminobutyric acid</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Shao‐Hui</creatorcontrib><creatorcontrib>Yuan, Tang‐Mi</creatorcontrib><creatorcontrib>Zhang, Jiao</creatorcontrib><creatorcontrib>Bai, Hua</creatorcontrib><creatorcontrib>Tian, Ming</creatorcontrib><creatorcontrib>Pan, Chu‐Xiong</creatorcontrib><creatorcontrib>Bao, Hong‐Guang</creatorcontrib><creatorcontrib>Jin, Xiao‐Ju</creatorcontrib><creatorcontrib>Ji, Fu‐Hai</creatorcontrib><creatorcontrib>Zhong, Tai‐Di</creatorcontrib><creatorcontrib>Wang, Qiang</creatorcontrib><creatorcontrib>Lv, Jian‐Rui</creatorcontrib><creatorcontrib>Wang, Sheng</creatorcontrib><creatorcontrib>Li, Yu‐Juan</creatorcontrib><creatorcontrib>Yu, Yong‐Hao</creatorcontrib><creatorcontrib>Luo, Ai‐Lin</creatorcontrib><creatorcontrib>Li, Xiang‐Kui</creatorcontrib><creatorcontrib>Min, Su</creatorcontrib><creatorcontrib>Li, Lin</creatorcontrib><creatorcontrib>Zou, Xiao‐Hua</creatorcontrib><creatorcontrib>Huang, Yu‐Guang</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Shao‐Hui</au><au>Yuan, Tang‐Mi</au><au>Zhang, Jiao</au><au>Bai, Hua</au><au>Tian, Ming</au><au>Pan, Chu‐Xiong</au><au>Bao, Hong‐Guang</au><au>Jin, Xiao‐Ju</au><au>Ji, Fu‐Hai</au><au>Zhong, Tai‐Di</au><au>Wang, Qiang</au><au>Lv, Jian‐Rui</au><au>Wang, Sheng</au><au>Li, Yu‐Juan</au><au>Yu, Yong‐Hao</au><au>Luo, Ai‐Lin</au><au>Li, Xiang‐Kui</au><au>Min, Su</au><au>Li, Lin</au><au>Zou, Xiao‐Hua</au><au>Huang, Yu‐Guang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non‐inferiority, phase III trial</atitle><jtitle>Journal of gastroenterology and hepatology</jtitle><addtitle>J Gastroenterol Hepatol</addtitle><date>2021-02</date><risdate>2021</risdate><volume>36</volume><issue>2</issue><spage>474</spage><epage>481</epage><pages>474-481</pages><issn>0815-9319</issn><eissn>1440-1746</eissn><abstract>Background and Aim Remimazolam tosilate (RT) is a new short‐acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. Methods This positive‐controlled, non‐inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. Results The success rate of sedation in the RT group was non‐inferior to that in the propofol group (97.34% vs 100.00%; difference in rate −2.66%, 95% CI −4.96 to −0.36, meeting criteria for non‐inferiority). Patients in the RT group had longer time to adequate sedation (P &lt; 0.0001) but shorter time to fully alert (P &lt; 0.0001) than that in the propofol group. The incidences of hypotension (13.04% vs 42.86%, P &lt; 0.0001), treatment‐related hypotension (0.54% vs 5.82%, P &lt; 0.0001), and respiratory depression (1.09% vs 6.88%, P = 0.0064) were significantly lower in the RT group. AEs were reported in 74 (39.15%) patients in the RT group and 114 (60.32%) patients in the propofol group, with significant difference (P &lt; 0.0001). Conclusion This trial established non‐inferior sedation success rate of RT compared with propofol. RT allows faster recovery from sedation compared with propofol. The safety profile is favorable and appears to be superior to propofol, indicating that it was feasible and well tolerated for patients.</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32677707</pmid><doi>10.1111/jgh.15188</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-6157-2198</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adverse events
Anesthesia
benzodiazepine
endoscopic sedation
Endoscopy
GABA (A) receptor agonist
Hypotension
Propofol
remimazolam
remimazolam tosilate
Safety
Success
upper gastrointestinal endoscopy
γ-Aminobutyric acid
title Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non‐inferiority, phase III trial
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