The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- total amount of opioid consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are scheduled to undergo catheter ablation for arrhythmia
排除标准
- •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
研究组 & 干预措施
propacetamol group
干预措施: Propacetamol (Drug)
placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
total amount of opioid consumption
时间窗: 1 day
Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.
次要结局
- Respiratory rate(1 day)
- recovery time(1 day)
- Depth of sedation(1 day)
- Post procedural pain(1 day)
- nausea point(1 day)
- number of vomiting(1 day)
- intra-procedural hemodynamics(1 day)
- satisfaction of patients(1 day)
- satisfaction of surgeons(1 day)