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The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study
https://repository.lib.tottori-u.ac.jp/records/4627
https://repository.lib.tottori-u.ac.jp/records/4627d3255fd2-9d0e-4b5a-9ed5-30d4df7f236b
名前 / ファイル | ライセンス | アクション |
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yam65(1)_14.pdf (840.3 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2022-03-09 | |||||
タイトル | ||||||
タイトル | The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study | |||||
言語 | en | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題 | anesthesia | |||||
キーワード | ||||||
主題 | dexmedetomidine | |||||
キーワード | ||||||
主題 | epidural | |||||
キーワード | ||||||
主題 | propofol | |||||
キーワード | ||||||
主題 | spinal | |||||
キーワード | ||||||
言語 | en | |||||
主題 | anesthesia | |||||
キーワード | ||||||
言語 | en | |||||
主題 | dexmedetomidine | |||||
キーワード | ||||||
言語 | en | |||||
主題 | epidural | |||||
キーワード | ||||||
言語 | en | |||||
主題 | propofol | |||||
キーワード | ||||||
言語 | en | |||||
主題 | spinal | |||||
資源タイプ | ||||||
資源タイプ | journal article | |||||
著者 |
稲垣, 喜三
× 稲垣, 喜三× Yamakage, Michiaki× Sakamoto, Atsuhiro× Okayama, Akifumi× Oya, Nobuyo× Hiraoka, Takehiko× Morita, Kiyoshi |
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著者所属(英) | ||||||
言語 | en | |||||
値 | Department of Anesthesiology and Critical Care Medicine, School of Medicine, Faculty of Medicine, Tottori University | |||||
著者所属(英) | ||||||
言語 | en | |||||
値 | Department of Anesthesiology, Sapporo Medical University School of Medicine | |||||
著者所属(英) | ||||||
言語 | en | |||||
値 | Department of Anesthesiology, Nippon Medical School | |||||
著者所属(英) | ||||||
言語 | en | |||||
値 | Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D | |||||
著者所属(英) | ||||||
言語 | en | |||||
値 | Clinical Development Department, Maruishi Pharmaceutical Co., Ltd. | |||||
著者所属(英) | ||||||
言語 | en | |||||
値 | Clinical Development Department, Maruishi Pharmaceutical Co., Ltd. | |||||
著者所属(英) | ||||||
言語 | en | |||||
値 | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | |||||
抄録 | ||||||
内容記述タイプ | Other | |||||
内容記述 | Background: Only a few studies have been reported on the use of dexmedetomidine for sedating surgical patients requiring epidural or spinal anesthesia. We conducted a randomized, double-blind, placebo-controlled, parallel-group study at 12 hospitals in Japan. Methods: Adult patients were randomly allocated to receive an intravenous administration of placebo or dexmedetomidine at 0.067, 0.25, 0.5 or 1.0 μg/kg over 10 min after epidural or spinal anesthesia. All dexmedetomidine groups received dexmedetomidine 0.2–0.7 μg/kg/h to maintain an Observer’s Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients who exceeded this score. Surgery was then started 15 min after study drug infusion in patients with OAA/S score of ≤ 4. The primary endpoint was the percentage of patients not requiring rescue propofol to achieve and maintain an OAA/S score of ≤ 4. Results: Of the 120 enrolled and randomized patients, 119 were treated the study: 22 received placebo and 97 received dexmedetomidine (23–25 patients per dose). Significantly more patients did not require propofol in the dexmedetomidine 0.5 and 1.0 μg/kg groups (68.0% and 80.0%, respectively) compared to the placebo group (22.7%) (P = 0.003 and P < 0.001, respectively). Common adverse events (AEs) were protocol-defined respiratory depression, bradycardia and hypotension. There was no significant difference in the incidence of AEs between the dexmedetomidine and the placebo groups. Conclusion: We concluded that loading doses of 0.5 and 1.0 μg/kg dexmedetomidine, followed by an infusion at a rate of 0.2–0.7 μg/kg/h, provide effective and well-tolerated sedation for surgical patients during epidural or spinal anesthesia. Clinical trials.gov identifier: NCT01438957 | |||||
書誌情報 |
Yonago Acta Medica en : Yonago Acta Medica 巻 65, 号 1, p. 14-25, 発行日 2022-02-22 |
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出版者 | ||||||
出版者 | Tottori University Medical Press | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 05135710 | |||||
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収録物識別子タイプ | NCID | |||||
収録物識別子 | AA00892882 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.33160/yam.2022.02.002 | |||||
権利 | ||||||
権利情報 | (C) 2022 Tottori University Medical Press. | |||||
情報源 | ||||||
関連名称 | Yonago Acta Medica. 2022, 65(1), 14-25. doi:10.33160/yam.2022.02.002 | |||||
関連サイト | ||||||
識別子タイプ | URI | |||||
関連識別子 | https://www.lib.tottori-u.ac.jp/yam/yam/yam65-1/65-1contents.html | |||||
関連名称 | https://www.lib.tottori-u.ac.jp/yam/yam/yam65-1/65-1contents.html | |||||
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識別子タイプ | DOI | |||||
関連識別子 | https://doi.org/10.33160/yam.2022.02.002 | |||||
関連名称 | https://doi.org/10.33160/yam.2022.02.002 | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
EISSN | ||||||
値 | 13468049 |