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The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan
https://repository.lib.tottori-u.ac.jp/records/4628
https://repository.lib.tottori-u.ac.jp/records/46284b0f2986-26db-43c5-87e0-0f9332d3de3f
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
yam65(1)_26.pdf (872.4 kB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2022-03-09 | |||||
| タイトル | ||||||
| タイトル | The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan | |||||
| 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 | local | |||||
| キーワード | ||||||
| 主題 | propofol | |||||
| 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 | local | |||||
| キーワード | ||||||
| 言語 | en | |||||
| 主題 | propofol | |||||
| 資源タイプ | ||||||
| 資源タイプ | journal article | |||||
| 著者 |
稲垣, 喜三
× 稲垣, 喜三× Morita, Kiyoshi× Ozaki, Makoto× Matsumoto, Kazuo× Okayama, Akifumi× Oya, Nobuyo× Hiraoka, Takehiko× Takeda, Junzo |
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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 | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | |||||
| 著者所属（英） | ||||||
| 言語 | en | |||||
| 値 | Department of Anesthesiology, Tokyo Women's Medical University | |||||
| 著者所属（英） | ||||||
| 言語 | en | |||||
| 値 | Department of Cardiology, Saitama Medical University International Medical Center / Higashimatsuyama Medical Association Hospital | |||||
| 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 | Department of Anesthesiology, Keio University School of Medicine / National Hospital Organization, Tokyo Medical Center | |||||
| 抄録 | ||||||
| 内容記述タイプ | Other | |||||
| 内容記述 | Background: Few studies (in other countries than the US) have reported on the efficacy and safety of dexmedetomidine for sedation of patients undergoing surgical or medical procedures under local anesthesia without intubation outside the intensive care unit. We performed a randomized, double-blind study in Japan. Methods: Adult patients were randomly allocated to receive placebo, dexmedetomidine 0.5 μg/kg (DEX 0.5 group), or dexmedetomidine 1.0 μg/kg (DEX 1.0 group) over 10 min. Then, both dexmedetomidine groups received dexmedetomidine 0.2–0.7 μg/kg/h for maintaining an Observer’s Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients whose score exceeded this value. The primary endpoint was the percentage of patients who did not require rescue propofol to achieve and maintain an OAA/S score of ≤ 4. Results: In total, 162 patients were included in the placebo (n = 53), DEX 0.5 (n = 53), and DEX 1.0 (n = 56) groups. Propofol was not required in significantly more patients in the dexmedetomidine 0.5 and 1.0 μg/kg groups (52.8% and 57.1%, respectively) compared with the placebo group (1.9%) (P < 0.001 for both). Common adverse events were protocol-defined hypotension, respiratory depression and bradycardia. The incidence of bradycardia was significantly higher in the DEX 0.5 (26.4%) and DEX 1.0 (30.4%) groups than in the placebo group (9.4%) (P = 0.041 and P = 0.008, respectively). Conclusion: We concluded that a loading dose of 0.5 or 1.0 μg/kg dexmedetomidine followed by infusion at a rate of 0.2–0.7 μg/kg/h provided effective and welltolerated sedation in patients undergoing surgical or medical procedures under local anesthesia without intubation. Clinical trials.gov identifier: NCT01438931 | |||||
| 書誌情報 |
Yonago Acta Medica en : Yonago Acta Medica 巻 65, 号 1, p. 26-43, 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 | |||||
| 書誌レコードID | ||||||
| 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.2022.02.005 | |||||
| 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), 26-43. doi:10.33160/yam.2022.02.005 | |||||
| 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 | |||||
| 関連サイト | ||||||
| 識別子タイプ | DOI | |||||
| 関連識別子 | https://doi.org/10.33160/yam.2022.02.005 | |||||
| 関連名称 | https://doi.org/10.33160/yam.2022.02.005 | |||||
| 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 | |||||
