| Project/Area Number |
15K20066
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Anesthesiology
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| Research Institution | Yokohama City University (2017-2018)
Kanagawa Children's Medical Center (Clinical Research Institute) (2015-2016) |
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Principal Investigator |
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| Research Collaborator |
Komazaki Maya
Ka Koui
Nakamura Nobuhito
Goto Takahisa
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| Project Period (FY) |
2015-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
Fiscal Year 2017: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2016: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2015: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
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| Keywords | ラメルテオン / 覚醒時興奮 / メラトニン / 覚醒時せん妄 |
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| Outline of Final Research Achievements |
Our meta-analysis has shown that melatonin premedication has a preventive effect on emergence agitation in children with a risk ratio of 0.31 (95% confidence interval: 0.16 to 0.60) compared to placebo. Our analysis also revealed that the total acquired number of patients was only 22% of the required sample size to obtain a definitive conclusion.
Our randomized controlled trial conducted after the meta-analysis has shown that ramelteon 0.1mg/kg premedication has no effect on emergence agitation in children, with a risk ratio of 1.0 (95% confidence interval: 0.67 to 1.46, P> 0.99) compared to placebo.
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| Academic Significance and Societal Importance of the Research Achievements |
小児麻酔後に起こる覚醒時興奮は，本人の自傷リスクを増加させる合併症である．よって覚醒時興奮の予防法開発が求められている．本邦で使用可能なメラトニン受容体アゴニストであるラメルテオンには覚醒時興奮予防効果が期待されていたが，本研究結果によりラメルテオン通常量による覚醒時せん妄予防効果は否定された．
本研究結果は直接的な臨床改善にはつながらなかったが，効果のない薬剤使用方法が明らかになり，無効な予防法が広まる事を防ぐ意味があったと考える．また，本研究では高用量ラメルテオンによる効果については否定できないので，将来的に高用量ラメルテオンによる有用性を検討する研究が必要と結論された．
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