{"created":"2025-03-03T10:54:12.876141+00:00","id":2036397,"links":{},"metadata":{"_buckets":{"deposit":"44fb25eb-d2d0-401d-822a-f55faba71d4f"},"_deposit":{"created_by":41,"id":"2036397","owners":[41],"pid":{"revision_id":0,"type":"depid","value":"2036397"},"status":"published"},"_oai":{"id":"oai:hiroshima.repo.nii.ac.jp:02036397","sets":["1727147343679:1730444856481:1730444861458"]},"author_link":[],"item_1617186331708":{"attribute_name":"Title","attribute_value_mlt":[{"subitem_title":"全身麻酔下における小児患者に対するレミフェンタニル塩酸塩の有効性及び安全性評価のための第Ⅲ相単群非盲検試験","subitem_title_language":"ja"},{"subitem_title":"A Phase III Multicenter, Open-Label, One-Arm Study to Evaluate the Efficacy and Safety of Remifentanil Hydrochloride for Pediatric Subjects under General Anesthesia","subitem_title_language":"en"}]},"item_1617186419668":{"attribute_name":"Creator","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"鈴木, 康之","creatorNameLang":"ja"},{"creatorName":"Suzuki, Yasuyuki","creatorNameLang":"en"}],"familyNames":[{"familyName":"鈴木","familyNameLang":"ja"},{"familyName":"Suzuki","familyNameLang":"en"}],"givenNames":[{"givenName":"康之","givenNameLang":"ja"},{"givenName":"Yasuyuki","givenNameLang":"en"}]},{"creatorNames":[{"creatorName":"今中, 啓一郎","creatorNameLang":"ja"},{"creatorName":"Imanaka, Keiichiro","creatorNameLang":"en"}],"familyNames":[{"familyName":"今中","familyNameLang":"ja"},{"familyName":"Imanaka","familyNameLang":"en"}],"givenNames":[{"givenName":"啓一郎","givenNameLang":"ja"},{"givenName":"Keiichiro","givenNameLang":"en"}]},{"creatorNames":[{"creatorName":"伊豆本, 透","creatorNameLang":"ja"},{"creatorName":"Izumoto, Tohru","creatorNameLang":"en"}],"familyNames":[{"familyName":"伊豆本","familyNameLang":"ja"},{"familyName":"Izumoto","familyNameLang":"en"}],"givenNames":[{"givenName":"透","givenNameLang":"ja"},{"givenName":"Tohru","givenNameLang":"en"}]},{"creatorNames":[{"creatorName":"柴田, さより","creatorNameLang":"ja"},{"creatorName":"Shibata, Sayori","creatorNameLang":"en"}],"familyNames":[{"familyName":"柴田","familyNameLang":"ja"},{"familyName":"Shibata","familyNameLang":"en"}],"givenNames":[{"givenName":"さより","givenNameLang":"ja"},{"givenName":"Sayori","givenNameLang":"en"}]},{"creatorNames":[{"creatorName":"名執, 真希子","creatorNameLang":"ja"},{"creatorName":"Natori, Makiko","creatorNameLang":"en"}],"familyNames":[{"familyName":"名執","familyNameLang":"ja"},{"familyName":"Natori","familyNameLang":"en"}],"givenNames":[{"givenName":"真希子","givenNameLang":"ja"},{"givenName":"Makiko","givenNameLang":"en"}]},{"creatorNames":[{"creatorName":"髙, 忠石","creatorNameLang":"ja"},{"creatorName":"Koh, Tadaishi","creatorNameLang":"en"}],"familyNames":[{"familyName":"髙","familyNameLang":"ja"},{"familyName":"Koh","familyNameLang":"en"}],"givenNames":[{"givenName":"忠石","givenNameLang":"ja"},{"givenName":"Tadaishi","givenNameLang":"en"}]}]},"item_1617186476635":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_abf2"}]},"item_1617186609386":{"attribute_name":"Subject","attribute_value_mlt":[{"subitem_subject":"レミフェンタニル","subitem_subject_scheme":"Other"},{"subitem_subject":"麻酔","subitem_subject_scheme":"Other"},{"subitem_subject":"小児","subitem_subject_scheme":"Other"},{"subitem_subject":"有効性","subitem_subject_scheme":"Other"},{"subitem_subject":"安全性","subitem_subject_scheme":"Other"},{"subitem_subject":"remifentanil","subitem_subject_scheme":"Other"},{"subitem_subject":"anesthesia","subitem_subject_scheme":"Other"},{"subitem_subject":"pediatric","subitem_subject_scheme":"Other"},{"subitem_subject":"efficacy","subitem_subject_scheme":"Other"},{"subitem_subject":"safety","subitem_subject_scheme":"Other"},{"subitem_subject":"490","subitem_subject_scheme":"NDC"}]},"item_1617186626617":{"attribute_name":"Description","attribute_value_mlt":[{"subitem_description":"レミフェンタニル塩酸塩は4-アニリドピペリジン誘導体で選択的μ-オピオイド受容体作動薬として，国内では，成人における「全身麻酔の導入及び維持における鎮痛」の効能・効果で汎用されているが，小児の適応はない。今回，小児におけるレミフェンタニル塩酸塩の有効性，安全性及び薬物動態を評価するため，挿管による気道確保及びオピオイド鎮痛薬による鎮痛を必要とする全身麻酔下での手術を行った1～15歳の小児患者80例を対象に，第Ⅲ相多施設単群非盲検試験を実施した。主要評価項目の皮膚切開時の刺激への反応は11.3％で，年齢区分（1～6歳，7～15歳）による明らかな差は認められなかった。本剤の使用に関連する有害事象は30.0％で，主な事象は心拍数減少であった。レミフェンタニルのクリアランスと年齢に明らかな傾向は認められなかった。レミフェンタニル塩酸塩は全身麻酔下の小児患者において，十分な鎮痛効果を認め，安全に使用可能であった。","subitem_description_language":"ja"},{"subitem_description":"Remifentanil is a potent, selective, 4-anilidopiperidine µ- opioid receptor agonist not licensed for analgesia in the maintenance of general anesthesia in pediatric subjects in Japan.　A phase III trial was conducted to evaluate remifentanil for pediatric subjects in Japan.　This multicenter, open-label, one-arm study in pediatric subjects between 1 and 15 years of age receiving general anesthesia included 80 subjects.　Nine subjects (11.3%) showed response to skin incision, which was the primary endpoint, and no apparent difference in response rate was found according to age (1–6, and 7–15 years old).　Drug-related treatment emergent adverse events were found in 24 subjects (30.0%) with the most common event being heart rate decreased (26.3%).　Remifentanil was found to be effective and safe for analgesia in maintenance of general anesthesia for pediatric subjects.","subitem_description_language":"en"}]},"item_1617186643794":{"attribute_name":"Publisher","attribute_value_mlt":[{"subitem_publisher":"広島麻酔医学会"}]},"item_1617186702042":{"attribute_name":"Language","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_1617186920753":{"attribute_name":"Source Identifier","attribute_value_mlt":[{"subitem_source_identifier":"0385-1664","subitem_source_identifier_type":"ISSN"},{"subitem_source_identifier":"AN00232251","subitem_source_identifier_type":"NCID"}]},"item_1617187024783":{"attribute_name":"開始ページ","attribute_value_mlt":[{"subitem_start_page":"33"}]},"item_1617187056579":{"attribute_name":"bibliographic_information","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2016-06-20","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"2","bibliographicPageEnd":"41","bibliographicPageStart":"33","bibliographicVolumeNumber":"52","bibliographic_titles":[{"bibliographic_title":"麻酔と蘇生"},{"bibliographic_title":"Ansesthesia and Resuscitation"}]}]},"item_1617258105262":{"attribute_name":"item_1617258105262","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_1617265215918":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_1617605131499":{"attribute_name":"File","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_access","date":[{"dateType":"Available","dateValue":"2023-03-18"}],"displaytype":"simple","filename":"AnesthResus_52_33.pdf","filesize":[{"value":"2.4 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