Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation; Catheter Ablation
• Interventions: Procedure: Acupuncture plus morphine

• Registration Number: NCT05575544
• Lead Sponsor: Shanghai Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-08
• Last Update Submitted: 2022-10-08
• Study Start: 2022-10-11
• Study First Posted: 2022-10-12
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left PVI ablation electroacupuncture group	Acupuncture plus morphine	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.
Right PVI ablation electroacupuncture group	Acupuncture plus morphine	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.

Primary Outcome Measures

Name	Time	Method
The severity of intraprocedural pain during the catheter ablation procedure	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	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.

Secondary Outcome Measures

Name	Time	Method
The dose of morphine used during the catheter ablation procedure	up to 1 month after enrollment	To compare the dose of morphine used during pulmonary vein isolation procedure.
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	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
the change of blood pressure during the catheter ablation procedure	up to 1 months after enrollment	Record the changes of blood pressure during the catheter ablation procedure