Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Atrial Fibrillation, Catheter Ablation

Intervention / Treatment
-----------------
* Procedure: Acupuncture plus morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 80 years old; Atrial fibrillation Nonresponse or intolerance to ≥1 antiarrhythmic drug. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left PVI ablation electroacupuncture group<br>Patient undergo right pulmonary vein isolation under general anesthesia.After successful isolation of the right pulmonary vein, use a 25-gauge stainless steel millineedle of different lengths to be ordered sequentially according to the acupuncture point prescription.Acupuncture was performed at Hegu and Neiguan points on the left side of the patient.After the manual acupuncture, the point was continuously stimulated by an electrical stimulator to analgesia,the frequency is 200 times / min, the pulse frequency is 3   4Hz. The output intensity is subject to the patient's tolerance, generally 20mA.The electroneedle stimulates until the end of the left pulmonary vein isolation. | Procedure: Acupuncture plus morphine<br>* The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure<br>|
| Experimental: Right PVI ablation electroacupuncture group<br>Patient undergo left pulmonary vein isolation under general anesthesia.After successful isolation of the left pulmonary vein, use a 25-gauge stainless steel millineedle of different lengths to be ordered sequentially according to the acupuncture point prescription.Acupuncture was performed at Hegu and Neiguan points on the left side of the patient.After the manual acupuncture, the point was continuously stimulated by an electrical stimulator to analgesia,the frequency is 200 times / min, the pulse frequency is 3   4Hz. The output intensity is subject to the patient's tolerance, generally 20mA.The electroneedle stimulates until the end of the right pulmonary vein isolation. | Procedure: Acupuncture plus morphine<br>* The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of intraprocedural pain during the catheter ablation procedure | 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. | up to 1 month after enrollment | 
| The severity of intraprocedural nausea during the catheter ablation procedure | 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. | up to 1 month after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of morphine used during the catheter ablation procedure | To compare the dose of morphine used during pulmonary vein isolation procedure. | up to 1 month after enrollment | 
| the change of blood pressure during the catheter ablation procedure | Record the changes of blood pressure during the catheter ablation procedure | up to 1 months 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 | death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding | up to 6 months after enrollment |