{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T18:19:50Z","timestamp":1787854790943,"version":"build-2784847793"},"reference-count":17,"publisher":"S. Karger AG","issue":"6","license":[{"start":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T00:00:00Z","timestamp":1721952000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T00:00:00Z","timestamp":1721952000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Digestion"],"abstract":"<jats:p>Introduction: We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopies. Methods: This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation with remimazolam (initial dose: 3 mg; additional dose: 1 mg) or normal saline (placebo). The primary endpoint of the study was the successful sedation rate during colonoscopy, defined as achieving a Modified Observer\u2019s Assessment of Alertness\/Sedation (MOAA\/S) score of \u22644 before the procedure, maintaining this score throughout colonoscopy, and requiring no more than five additional drug doses per 15 min. Results: The sedation success rate was 95.0% (38\/40 patients) in the remimazolam group and 0.0% (0\/11 patients) in the placebo group (p &lt; 0.01). The time from the end of procedure to regaining consciousness was 0.0 (interquartile range: 0.0\u20130.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 (interquartile range: 0.0\u201310.0) min in the remimazolam group and 0.0 (interquartile range: 0.0\u20130.0) min in the placebo group (p = 0.02). Serious adverse events were not observed. Conclusion: The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than placebo.<\/jats:p>","DOI":"10.1159\/000540527","type":"journal-article","created":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T17:11:25Z","timestamp":1722013885000},"page":"448-456","source":"Crossref","is-referenced-by-count":10,"title":["Randomized Controlled Trial of Remimazolam Compared with Placebo in Japanese Patients Undergoing Colonoscopy: A Phase III, Investigator-Initiated Trial"],"prefix":"10.1159","volume":"105","author":[{"given":"Ryoji","family":"Ichijima","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9239-7495","authenticated-orcid":false,"given":"Hisatomo","family":"Ikehara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Ono","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5608-0968","authenticated-orcid":false,"given":"Kinichi","family":"Hotta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9782-9998","authenticated-orcid":false,"given":"Daisuke","family":"Yamaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7353-2153","authenticated-orcid":false,"given":"Mitsuru","family":"Esaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Minoda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiko","family":"Nagata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanako","family":"Ogura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinsuke","family":"Kiriyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Sumiyoshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichi","family":"Kanmura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2024,7,26]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199312303292701"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2020-321996"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.347"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1111\/den.13882"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1111\/den.14365"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1007\/s00540-020-02788-6"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000020765"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.2334\/josnusd.21-0051"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.655042"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2020.10.039"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016\/j.gie.2018.04.2351"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1016\/j.gie.2015.08.062"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e3182a705ae"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.900723"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0000000000000548"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.15188"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1097\/00004714-199008000-00003"}],"container-title":["Digestion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/dig\/article-pdf\/105\/6\/448\/4310846\/000540527.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/dig\/article-pdf\/105\/6\/448\/4310846\/000540527.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T11:32:39Z","timestamp":1745407959000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000540527"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,26]]},"references-count":17,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2024,12,9]]},"published-print":{"date-parts":[[2024,12,11]]}},"URL":"https:\/\/doi.org\/10.1159\/000540527","archive":["Portico"],"relation":{},"ISSN":["0012-2823","1421-9867"],"issn-type":[{"value":"0012-2823","type":"print"},{"value":"1421-9867","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,26]]}}}