Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Shanghai Chest Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Atrial Fibrillation Catheter Ablation

Interventions

Acupuncture plus morphinePROCEDURE

The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 to 80 years old; 2. Atrial fibrillation 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug. Exclusion Criteria: 1. A history of allergy to acupuncture; 2. With uncontrolled congestive heart failure; 3. Having significant valvular disease; 4. Having moderate-to-severe pulmonary hypertension; 5. With myocardial infarction or stroke within 6 months of screening; 6. With Significant congenital heart disease; 7. Ejection fraction was \<40% measured by echocardiography; 8. Allergic to contrast media; 9. Contraindication to anticoagulation medications; 10. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); 11. Left atrial thrombus; 12. Having any contraindication to right or left sided heart catheterization

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 1 month after enrollment

Secondary Outcomes

The dose of morphine used during the catheter ablation procedure

To compare the dose of morphine used during pulmonary vein isolation procedure.

Time frame: 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

Time frame: up to 1 months after enrollment

Change of the the radio of IL6/IL10 before and after the ablation procedure

Time frame: 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

Data from ClinicalTrials.gov

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