{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:47:57Z","timestamp":1787014077407,"version":"build-2736575974"},"reference-count":19,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T00:00:00Z","timestamp":1708819200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Digestive Endoscopy"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the effectiveness of remimazolam against normal saline (placebo) as a sedative agent for endoscopy in a multicenter, randomized, double\u2010blind, investigator\u2010initiated phase III controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We included 48 Japanese patients undergoing upper gastrointestinal endoscopy. For the procedure, an initial remimazolam dose of 3\u2009mg and additional doses of 1\u2009mg were administered, as determined in the phase II clinical study. The primary study end\u2010point was the successful sedation rate during gastrointestinal endoscopy, determined as a Modified Observer's Assessment of Alertness\/Sedation score\u2009\u22644 before the start of endoscopy, the completion of gastrointestinal endoscopy, and two or fewer additional doses per 6\u2009min.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The successful endoscopy sedation rates were 91.9% and 9.1% in the remimazolam and placebo groups, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.01). The time from the end of endoscopy to arousal was 0.0 (0.0\u20130.0) min for both groups. The number of additional doses required to achieve sedation was lower in the remimazolam group than that in the placebo group (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.01).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Remimazolam demonstrated a significantly higher sedation effect during upper gastrointestinal endoscopy in Japanese patients with safe and fast recovery compared with placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/den.14758","type":"journal-article","created":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T00:39:01Z","timestamp":1708907941000},"page":"995-1002","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Randomized controlled trial of remimazolam compared with placebo in Japanese patients undergoing upper gastrointestinal endoscopy: Phase III investigator\u2010initiated clinical trial"],"prefix":"10.1111","volume":"36","author":[{"given":"Ryoji","family":"Ichijima","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine  Tokyo Japan"},{"name":"Department of Gastroenterology Kiriyama Clinic  Gunma Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9239-7495","authenticated-orcid":false,"given":"Hisatomo","family":"Ikehara","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine  Tokyo Japan"},{"name":"Department of Gastroenterology, Internal Medicine Kitasato University School of Medicine  Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9782-9998","authenticated-orcid":false,"given":"Daisuke","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology National Hospital Organization Ureshino Medical Center  Saga Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiko","family":"Nagata","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Nagata Surgery and Gastroenterological Clinic  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanako","family":"Ogura","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine  Tokyo Japan"},{"name":"Department of Gastroenterology Nagata Surgery and Gastroenterological Clinic  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7353-2153","authenticated-orcid":false,"given":"Mitsuru","family":"Esaki","sequence":"additional","affiliation":[{"name":"Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences Kyushu University  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9567-9738","authenticated-orcid":false,"given":"Yosuke","family":"Minoda","sequence":"additional","affiliation":[{"name":"Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences Kyushu University  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Ono","sequence":"additional","affiliation":[{"name":"Division of Endoscopy Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Maeda","sequence":"additional","affiliation":[{"name":"Division of Endoscopy Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinsuke","family":"Kiriyama","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Kiriyama Clinic  Gunma Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9390-8477","authenticated-orcid":false,"given":"Tetsuya","family":"Sumiyoshi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Tonan Hospital  Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichi","family":"Kanmura","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology Fujimoto General Hospital  Miyazaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuji","family":"Gotoda","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine  Tokyo Japan"},{"name":"Department of Gastroenterology Cancer Institute Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,25]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/den.13882"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/den.12678"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5107(96)70091-3"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/den.14365"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00540-020-02788-6"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000020765"},{"key":"e_1_2_11_8_1","first-page":"4594","article-title":"The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: A multicentered, randomized, positive\u2010controlled, phase III clinical trial","volume":"12","author":"Chen S","year":"2020","journal-title":"Am J Transl Res"},{"key":"e_1_2_11_9_1","first-page":"929","article-title":"Remimazolam, a short\u2010acting GABA(A) receptor agonist for intravenous sedation and\/or anesthesia in day\u2010case surgical and non\u2010surgical procedures","volume":"13","author":"Rogers WK","year":"2010","journal-title":"IDrugs"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.2334\/josnusd.21-0051"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1358\/dot.2021.57.5.3264119"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.655042"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2020.10.039"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gie.2018.04.2351"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gie.2015.08.062"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e3182a705ae"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0000000000000548"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.15188"},{"key":"e_1_2_11_19_1","first-page":"244","article-title":"Validity and reliability of the Observer's Assessment of Alertness\/Sedation Scale: Study with intravenous midazolam","volume":"10","author":"Chernik DA","year":"1990","journal-title":"J Clin Psychopharmacol"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.201912-872OC"}],"container-title":["Digestive Endoscopy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/den.14758","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,18]],"date-time":"2025-02-18T23:48:29Z","timestamp":1739922509000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/den.14758"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,25]]},"references-count":19,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["10.1111\/den.14758"],"URL":"https:\/\/doi.org\/10.1111\/den.14758","archive":["Portico"],"relation":{},"ISSN":["0915-5635","1443-1661"],"issn-type":[{"value":"0915-5635","type":"print"},{"value":"1443-1661","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,25]]},"assertion":[{"value":"2023-09-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}