リウマチ性心疾患の妊婦における歯科麻酔
2008年6月4日 更新者:University of Sao Paulo
局所麻酔下での歯科治療中のリウマチ性心疾患患者の母体と胎児のモニタリング
リウマチ性弁疾患を有する 31 人の妊婦の血行力学的パラメーターが、リドカインの 2% 溶液による局所麻酔下で修復歯科を受け、1:100,000 エピネフリン溶液を含む (グループ LE) と含まない (グループ LNE) の 2 つのグループに分けられて研究されました。 3 つの標準的な期間中の 24 時間の外来心電図モニタリング、断続的な血圧モニタリング、連続心電図検査。
2つのグループの他の2つの期間と比較して、手順中に母体の心拍数の値の有意な減少が見られ、9人の心不整脈の発生(29.1%)が見られました。
エピネフリン麻酔を受けたグループの患者は 7 人 (41.8%) でした。
エピネフリンと併用した 2% リドカインの使用は、リウマチ性弁疾患の妊婦の歯科処置中に安全であることが証明されたと結論付けます。
調査の概要
詳細な説明
妊娠中、女性の器官系は、ホルモン、解剖学的、および代謝の変化に起因する生理学的変化を受けます。
循環器系の最も重要な変化は、妊娠の最初の 3 か月からの心拍出量の増加です。
心臓病の女性は、妊娠初期に適切な機能的能力を持っていると考えられている患者であっても、この血行動態の過負荷に体が不適切に適応するため、妊娠期間中に重篤な合併症を引き起こす可能性があります.
歯科処置で使用される、血管収縮剤の有無にかかわらず、局所麻酔薬がバルバー病の妊婦の心血管系の変数とその概念に及ぼす影響に関する研究は、文献にはほとんどありません。
この不足により、血圧(BP)に加えて、胎児心拍数(FHR)、胎児運動性(FM)、子宮収縮(UC)などの心血管パラメータを評価および分析することにより、この主題を研究することにしました。リウマチ性弁膜症の妊婦の心拍数 (HR) や期外収縮 (ES) などの心電図変数は、修復歯科処置中にリドカインによる局所麻酔 (血管収縮剤の有無にかかわらず) を受けます。
このために、妊娠 28 週から 37 週のリウマチ性心疾患患者 31 人が、24 時間外来で血圧とホルター心電図 (Holter-ECG) および心電図 (CTG) をモニタリングし、次の期間に実施しました: (1) ベースライン- BP および Holter-ECG モニタリングの手順の 60 分前、CTG の手順の 20 分前。 (2) 手順 - 56±15.5 分 (平均値±標準偏差)。 (3) 処置後 - 20 分。 (4) 平均 24 時間の HR および ES 測定、平均覚醒および睡眠期間の BP モニタリング。
上記の変数の変動は、2 つのグループで分析されました。1 つのグループは、血管収縮剤を含まないリドカインの 2% 溶液の注入 (グループ LNE) で構成され、14 人の患者で構成され、もう 1 つのグループは、リドカインの 2% 溶液とエピネフリン 1:100,000 の注入 (グループ LE) は 17 人の患者で構成され、無作為化された描画と単一のブラインド。
リドカインの溶液が使用されていた研究者の賢明な人物、したがって、適切な局所血管収縮は、それが浸潤されているかエピネフリンではないかを非難しました.
使用された技術は、変更された歯周靭帯 (PDLm 注射) であり、装置 The Wand を使用して、6 分で 1.8 ml (カートリッジ 1 個) を注入しました。
Vonesh と Shork の表 (15 人の患者各グループは、相関関係が次の値 0.4、5% の有意水準、および 80% のテストが可能であることの測定値を入力することを考慮して)。
すべての変数は、最初は記述的に分析されていました。
量的変数について、この分析は、最小値と最大値のコメント、および中間平均とシャント ライン標準の計算によって行われました。
質的変数については、絶対度数と相対度数を計算します。
テストに使用された有意水準は 5% (p<0.05) でした。処置中に得られた母体の HR 値は、2 つのグループの他の期間と比較してのみ有意な減少を示しました (P<0.001)。
グループ LE e LNE の比較では、有意差は明らかになりませんでした (P>0.05)。
9例でESが検出された(29.0%)
患者のうち 7 人 (41.8%) がグループ LE でした。
血圧は、期間間でもグループ間でも有意差を示さなかった (P>0.05)。
CTG中に得られた胎児パラメータの比較分析でも同じことが起こりました - UCの数、FHRのベースラインからのレベルと変動性、FHRの加速数、および胎児の反応性パターン。
私たちの結論は、エピネフリンと組み合わせたリドカインの2%溶液の使用は、リウマチ性心臓弁膜症の妊婦の歯科処置中に安全であることが証明された.
研究の種類
介入
入学 (実際)
31
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Sao Paulo、ブラジル、SP 05403-000
- Heart Institute (InCor) of University of São Paulo Medical School
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (アダルト、OLDER_ADULT)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
包含基準:
- 臨床基準:病歴および身体検査によって診断され、ドップラー心エコー検査によって記録されたリウマチ性弁膜症の女性で、妊娠前に外科的介入または経皮的介入を受けたかどうかにかかわらず、分類に応じて機能クラス(FC)IまたはIIの女性ニューヨーク心臓協会(NYHA)の。
- 産科基準: 1 胎児妊娠、在胎週数 (GA) 28 ~ 37 週。
- 歯科学的基準:総歯列または部分歯列で、齲歯(ブラック クラス I、II、および / または V)の発生、またはエッジ浸潤 臨床的および/またはX線撮影で診断された再発性齲蝕。
除外基準:
- 臨床基準:心不全、制御されていない慢性動脈性高血圧症、または複雑なおよび/または症候性心室性不整脈。
- 産科基準:子癇前症、子宮発育制限、分娩。
- 歯科学的基準:歯髄露出、歯髄炎、または歯髄壊死の臨床的および/または X 線写真による下顎前臼歯または大臼歯の虫歯、歯内療法または補綴によるリハビリテーションの予後を伴う歯冠の骨折または破壊、または抜歯の適応。
- 精神医学的基準:米国精神医学会(APA)の分類によると、パニック、広場恐怖症、社会的または特定の恐怖症、強迫性障害、心的外傷後ストレス、または化学的に誘発された不安などの不安障害の患者。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:平行
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:グループLE
グループ LE を構成する 17 例 (54.8%) の患者は、エピネフリン 1:100,000 を含む 2% リドカイン溶液の歯周靭帯への修正麻酔による 1.8 mL (1 カートリッジ) の注入 (PDLm 注射) にランダムに割り当てられました。
年齢は 18 歳から 44 歳 (平均 29.6 歳) で、
彼らは、NYHAの分類に従って機能クラスIまたはIIのリウマチ性弁疾患を有すると診断されました。
妊娠期間は 28 ~ 36 週 (平均 31.8 週) でした。
BMI は 18.7 から 32.9 (平均値: 23.8)
キロ/平方メートル。
すべての患者は、下の前臼歯および/または大臼歯で行われた修復を受けました。
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他の名前:
他の名前:
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ACTIVE_COMPARATOR:グループLNE
グループ LNE を構成する 14 人 (45.2%) の患者は、エピネフリンを含まない 2% リドカイン溶液の歯周靭帯への修正麻酔による 1.8 mL (1 カートリッジ) の注入 (PDLm 注射) にランダムに割り当てられました。
年齢は 22 歳から 33 歳 (平均 26.6 歳) で、
彼らは、NYHAの分類に従って機能クラスIまたはIIのリウマチ性弁疾患を有すると診断されました。
妊娠期間は 29 ~ 37 週 (平均 32.1 週) でした。
BMI は 18.5 から 38.1 (平均値: 22.8)
キロ/平方メートル。
すべての患者は、下の前臼歯および/または大臼歯で行われた修復を受けました。
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他の名前:
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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母体:血圧、心拍数、期外収縮。母体-胎児: 胎児の心拍数、子宮収縮の数、運動性および胎児の反応性パターン、エピネフリンの存在または非存在の機能におけるリドカインの 2% 溶液中の 1:100000
時間枠:4 期間母体: (1) ベースライン - 手順の 60 分前、(2) 手順、(3) 手順後 - 20 分、および (4) 平均 24 時間。 3 期間の母体-胎児: (1) ベースライン: 20 分前、(2) 処置、および (3) 処置後 - 同上母体
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4 期間母体: (1) ベースライン - 手順の 60 分前、(2) 手順、(3) 手順後 - 20 分、および (4) 平均 24 時間。 3 期間の母体-胎児: (1) ベースライン: 20 分前、(2) 処置、および (3) 処置後 - 同上母体
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二次結果の測定
結果測定 |
時間枠 |
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それらは、妊娠期間(GA)の関数として、一次結果測定に使用されたのと同じ分析でした:サブグループGA1(28〜31週の妊婦15人)およびサブグループGA2(28〜31週の妊婦16人)週間)。
時間枠:それらは、主要な結果測定の時間枠に対して設定された同じ期間でした
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それらは、主要な結果測定の時間枠に対して設定された同じ期間でした
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Itamara LI Neves, PhD、Heart Institute (InCor) of University of São Paulo Medical School - Sao Paulo, Brazil
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2004年4月1日
一次修了 (実際)
2005年7月1日
研究の完了 (実際)
2006年1月1日
試験登録日
最初に提出
2007年6月4日
QC基準を満たした最初の提出物
2007年6月4日
最初の投稿 (見積もり)
2007年6月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2008年6月5日
QC基準を満たした最後の更新が送信されました
2008年6月4日
最終確認日
2008年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CAPPesq 009/03
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歯科局所麻酔の臨床試験
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Saint-Joseph University完了
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University of Michigan完了