The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
Sedation for catheter ablation of atrial fibrillation should be performed to achieve analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However, propofol and midazolam causes respiratory depression and dexmedetomidine occasionally accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that does not induce respiratory depression with stable hemodynamics is needed.
Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators hypothesized that addition of propacetamol to previously used sedatives midazolam-remifentanil will reduce opioid consumption during the catheter ablation.
Therefore, the investigators designed this study to investigate the role of addition of propacetamol to previous used midazolam-remifentanil sedation. This study will compare the opioid consumption and respiratory effect of propacetamol with placebo-control for catheter ablation of atrial fibrillation.
調査の概要
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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Seoul、大韓民国、120-752
- Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
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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:
- patients who are scheduled to undergo catheter ablation for arrhythmia
Exclusion Criteria:
- Subjects are ineligible if they have liver disease, kidney disease,
- American society of anesthesiology class 3 or 4,
- age under 20 years,
- cognitive dysfunction,
- disabling mental change disorder,
- patients are unable to communicate or speak Korean
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
- 主な目的：支持療法
- 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 |
|---|---|
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プラセボコンパレーター：プラセボ群
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Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
他の名前：
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実験的：propacetamol group
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Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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total amount of opioid consumption
時間枠：1 day
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Total opioid consumption during the procedure will be recorded.
And post procedural consumption of analgesics also will be recorded.
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1 day
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Respiratory rate
時間枠：1 day
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1 day
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Depth of sedation
時間枠：1 day
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depth of sedation measured by Ramsay Sedation Score
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1 day
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Post procedural pain
時間枠：1 day
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post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)
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1 day
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nausea point
時間枠：1 day
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nausea measured by 11-point NRS (Numerical Rating Scale)
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1 day
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number of vomiting
時間枠：1 day
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1 day
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intra-procedural hemodynamics
時間枠：1 day
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intra-procedural hemodynamics measured by amount of used vasopressors
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1 day
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satisfaction of patients
時間枠：1 day
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satisfaction of patient and surgeons measured by 5-point NRS
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1 day
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recovery time
時間枠：1 day
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monitored with heart rate and blood pressure
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1 day
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satisfaction of surgeons
時間枠：1 day
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satisfaction of patient and surgeons measured by 5-point NRS
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1 day
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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 (実際)
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 (実際)
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
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