A Randomized Control Trial to Determine Whether Electroacupuncture(EA) Intervention With Morphine Can Reduce the Intraoperative Pain and Early Post-operative Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- The severity of intraprocedural pain during the catheter ablation procedure
研究概览
简要总结
This is a randomized control trial to determine whether electroacupuncture(EA) intervention with Morphine can reduce the intraoperative pain and early post-operative complications in patients undergoing 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years old;
- •Atrial fibrillation
- •Nonresponse or intolerance to ≥1 antiarrhythmic drug.
排除标准
- •A history of allergy to acupuncture;
- •With uncontrolled congestive heart failure;
- •Having significant valvular disease;
- •Having moderate-to-severe pulmonary hypertension;
- •With myocardial infarction or stroke within 6 months of screening;
- •With Significant congenital heart disease;
- •Ejection fraction was <40% measured by echocardiography;
- •Allergic to contrast media;
- •Contraindication to anticoagulation medications;
- •Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- •Left atrial thrombus;
- •Having any contraindication to right or left sided heart catheterization
结局指标
主要结局
The severity of intraprocedural pain during the catheter ablation procedure
时间窗: up to 1 month after enrollment
Pain was assessed by Visual Analogue Score (VAS).VAS is one of the commonly used pain scoring standards. The full name is the visual simulation scoring method. The pain is divided into 10 points, 2 points for no pain, 10 points for severe pain, and the middle part for different degrees of pain.To compare the scores of patients during pulmonary vein isolation procedure.
The severity of intraprocedural nausea during the catheter ablation procedure
时间窗: up to 1 month after enrollment
The incidence of nausea, vomiting and retching within 12 hours after operation was recorded, including 3 dimensions of symptom experience time, frequency and severity, with 8 items in total. 0\~4 points shall be used for 5 grades. 0 points means none at all, and 4 points means very serious and intolerable.
次要结局
- The dose of morphine used during the catheter ablation procedure(up to 1 month after enrollment)
- Change of the the radio of IL6/IL10 before and after the ablation procedure(up to 1 months after enrollment)
- Incidence of complications(up to 6 months after enrollment)
- the change of blood pressure during the catheter ablation procedure(up to 1 months after enrollment)
研究者
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital