Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
調査の概要
状態
詳細な説明
Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.
Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine.
Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Seoul、大韓民国、135-710
- Samsung Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center
Exclusion Criteria:
- Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
- Patients with recent exogenous steroid administration or previous diuretics therapy
- Patients with recent myocardial infarction
- Those undergoing unplanned cardiopulmonary bypass during the surgery
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Lidocaine group
a bolus dose of lidocaine 1.5 mg/kg after anesthetic induction with following lidocaine infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
|
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
他の名前：
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実験的：Dexmedetomidine group
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
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Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
他の名前：
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実験的：Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
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a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
他の名前：
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
他の名前：
|
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介入なし：Control group
The group without infusion of lidocaine or dexmedetomidine
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Myocardial injury marker
時間枠：postoperative ICU day 1
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Myocardial injury marker - CK-MB, and Troponin(i) blood level
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postoperative ICU day 1
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Myocardial injury marker
時間枠：postoperative ICU day 2
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Myocardial injury marker - CK-MB, and Troponin(i) blood level
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postoperative ICU day 2
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Myocardial injury marker
時間枠：postoperative ICU day 3
|
Myocardial injury marker - CK-MB, and Troponin(i) blood level
|
postoperative ICU day 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The blood sodium, potassium, calcium level
時間枠：1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
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The blood sodium, potassium, calcium level
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1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
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The incidence of arrhythmia during and after the surgery
時間枠：1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
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The incidence of arrhythmia during and after the surgery: Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing |
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
|
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Postoperative ICU stay, Hospital stay, Extubation time
時間枠：1 day after hospital discharge
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Postoperative ICU stay, Hospital stay
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1 day after hospital discharge
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Inotropics use during and after the surgery
時間枠：1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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Inotropics and other drug use during and after the surgery: Dopamine, NTG, dobutamine, milrinone, epinephrine, norepinephrine, amiodarone, diltiazem, remifentanil, esmolol, labetalol, nicardipine, Lasix, phenylephrine, lidocaine, sufentanil
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1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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The incidence of hypokalemia
時間枠：1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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The incidence of hypokalemia
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1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 2012-07-098-001
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