{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T01:51:15Z","timestamp":1778809875554,"version":"3.51.4"},"reference-count":35,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T00:00:00Z","timestamp":1664496000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Introduction<\/jats:title>\n<jats:p>In geriatric patients, hypotension is often reported after general anesthesia induction using propofol. Remimazolam is a novel short-acting sedative. However, the incidence of hypotension after general anesthesia induction using remimazolam in geriatric patients remains unclear. This study aims to compare the incidence of hypotension associated with remimazolam and propofol in patients aged \u226580 years.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>This single-center, double-blind, randomized, two-arm parallel group, standard treatment-controlled, interventional clinical trial will include 90 patients aged \u226580 years undergoing elective surgery under general anesthesia who will be randomized to receive remimazolam or propofol for induction. The primary outcome is the incidence of hypotension after general anesthesia induction, occurring between the start of drug administration and 3 min after intubation. We define hypotension as mean blood pressure &lt;65 mmHg. The primary outcome will be analyzed using the full analysis set. The incidence of hypotension in the two groups will be compared using the Mantel-Haenszel \u03c72 test. Subgroup analysis of the primary outcome will be performed based on the Charlson comorbidity index, clinical frailty scale, hypertension in the ward, and age. Secondary outcomes will be analyzed using the Fisher\u2019s exact test, Student\u2019s <jats:italic>t<\/jats:italic> test, and Mann\u2013Whitney <jats:italic>U<\/jats:italic> test, as appropriate. Logistic regression analysis will be performed to explore the factors associated with the incidence of hypotension after anesthesia induction.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>Our trial will determine the efficacy of remimazolam in preventing hypotension and provide evidence on the usefulness of remimazolam for ensuring hemodynamic stability during general anesthesia induction in geriatric patients.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>The study has been registered with UMIN Clinical Trials Registry (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/center6.umin.ac.jp\/cgi-open-bin\/ctr_e\/ctr_view.cgi?recptno=R000048218\" xlink:type=\"simple\">UMIN000042587<\/jats:ext-link>), on June 30, 2021.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0275451","type":"journal-article","created":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T17:43:27Z","timestamp":1664559807000},"page":"e0275451","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":17,"title":["Hypotension after general anesthesia induction using remimazolam in geriatric patients: Protocol for a double-blind randomized controlled trial"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5605-5305","authenticated-orcid":true,"given":"Masashi","family":"Yokose","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryuki","family":"Takaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Mihara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuke","family":"Saigusa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natsuhiro","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenichi","family":"Masui","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahisa","family":"Goto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2022,9,30]]},"reference":[{"key":"pone.0275451.ref001","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1097\/01.anes.0000267503.85085.c0","article-title":"CNS 7056: a novel ultra-short-acting Benzodiazepine","volume":"107","author":"GJ Kilpatrick","year":"2007","journal-title":"Anesthesiology"},{"key":"pone.0275451.ref002","doi-asserted-by":"crossref","first-page":"415","DOI":"10.1016\/j.bja.2021.05.027","article-title":"Pharmacokinetic properties of remimazolam in subjects with hepatic or renal impairment","volume":"127","author":"T St\u00f6hr","year":"2021","journal-title":"Br J Anaesth"},{"key":"pone.0275451.ref003","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1007\/s40265-020-01299-8","article-title":"Remimazolam: first approval.","volume":"80","author":"SJ Keam","year":"2020","journal-title":"Drugs"},{"key":"pone.0275451.ref004","doi-asserted-by":"crossref","first-page":"622","DOI":"10.1213\/01.ANE.0000175214.38450.91","article-title":"Predictors of hypotension after induction of general anesthesia.","volume":"101","author":"DL Reich","year":"2005","journal-title":"Anesth Analg."},{"key":"pone.0275451.ref005","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1093\/bja\/aex127","article-title":"Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia","volume":"119","author":"S S\u00fcdfeld","year":"2017","journal-title":"Br J Anaesth"},{"key":"pone.0275451.ref006","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1007\/s00540-018-2532-6","article-title":"Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. 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Population Estimates by Age (Five-Year Groups) and Sex\u2014May 1, 2021 (Final estimates), October 1, 2021 (Provisional estimates). 2021 [cited 20 October 2021]. In: Portal Site of Official Statistics of Japan [internet]. Available from: https:\/\/www.e-stat.go.jp\/en\/stat-search\/files?page=1&layout=datalist&toukei=00200524&tstat=000000090001&cycle=1&year=20210&month=24101210&tclass1=000001011678&tclass2val=0"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0275451","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T17:44:06Z","timestamp":1664559846000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0275451"}},"subtitle":[],"editor":[{"given":"Walid Kamal","family":"Abdelbasset","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2022,9,30]]},"references-count":35,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2022,9,30]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0275451","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,30]]}}}