Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Catheter Ablation
• Intervention / Treatment: Procedure: Acupuncture plus morphine

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Left PVI ablation electroacupuncture group; 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; The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure
EXPERIMENTAL: Right PVI ablation electroacupuncture group; 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; The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 11, 2022
• Primary Completion (ANTICIPATED): October 11, 2023
• Study Completion (ANTICIPATED): October 13, 2023

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (ACTUAL): October 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: EAAF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No