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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul、大韩民国、120-752
- Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:安慰剂组
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Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
其他名称:
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实验性的: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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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total amount of opioid consumption
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Respiratory rate
大体时间:1 day
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1 day
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Depth of sedation
大体时间: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
大体时间: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
大体时间: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
大体时间:1 day
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1 day
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intra-procedural hemodynamics
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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