Item type |
学術雑誌論文 / Journal Article(1) |
公開日 |
2022-03-09 |
タイトル |
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言語 |
en |
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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 |
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言語 |
eng |
キーワード |
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主題Scheme |
Other |
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主題 |
anesthesia |
キーワード |
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主題Scheme |
Other |
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主題 |
dexmedetomidine |
キーワード |
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主題Scheme |
Other |
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主題 |
epidural |
キーワード |
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主題Scheme |
Other |
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主題 |
propofol |
キーワード |
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主題Scheme |
Other |
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主題 |
spinal |
キーワード |
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言語 |
en |
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主題Scheme |
Other |
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主題 |
anesthesia |
キーワード |
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言語 |
en |
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主題Scheme |
Other |
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主題 |
dexmedetomidine |
キーワード |
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言語 |
en |
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主題Scheme |
Other |
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主題 |
epidural |
キーワード |
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言語 |
en |
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主題Scheme |
Other |
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主題 |
propofol |
キーワード |
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言語 |
en |
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主題Scheme |
Other |
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主題 |
spinal |
資源タイプ |
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資源タイプ |
journal article |
著者 |
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) |
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en |
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Department of Anesthesiology and Critical Care Medicine, School of Medicine, Faculty of Medicine, Tottori University |
著者所属(英) |
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en |
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Department of Anesthesiology, Sapporo Medical University School of Medicine |
著者所属(英) |
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en |
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Department of Anesthesiology, Nippon Medical School |
著者所属(英) |
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en |
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Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D |
著者所属(英) |
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en |
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Clinical Development Department, Maruishi Pharmaceutical Co., Ltd. |
著者所属(英) |
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en |
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Clinical Development Department, Maruishi Pharmaceutical Co., Ltd. |
著者所属(英) |
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en |
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Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science |
抄録 |
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内容記述タイプ |
Other |
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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 |
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出版者 |
Tottori University Medical Press |
ISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
05135710 |
書誌レコードID |
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収録物識別子タイプ |
NCID |
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収録物識別子 |
AA00892882 |
DOI |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
DOI |
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関連識別子 |
10.33160/yam.2022.02.002 |
権利 |
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権利情報 |
(C) 2022 Tottori University Medical Press. |
情報源 |
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関連名称 |
Yonago Acta Medica. 2022, 65(1), 14-25. doi:10.33160/yam.2022.02.002 |
関連サイト |
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識別子タイプ |
URI |
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関連識別子 |
https://www.lib.tottori-u.ac.jp/yam/yam/yam65-1/65-1contents.html |
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関連名称 |
https://www.lib.tottori-u.ac.jp/yam/yam/yam65-1/65-1contents.html |
関連サイト |
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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.33160/yam.2022.02.002 |
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関連名称 |
https://doi.org/10.33160/yam.2022.02.002 |
著者版フラグ |
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出版タイプ |
VoR |
EISSN |
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13468049 |