Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

NCT05575544 | Unknown

• 1 other identifier: EAAF
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Catheter Ablation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The dose of morphine used during the catheter ablation procedure

  up to 1 month after enrollment

• the change 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

  up to 6 months after enrollment

Study Arms (2)

Left PVI ablation electroacupuncture group

EXPERIMENTAL

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

Right PVI ablation electroacupuncture group

EXPERIMENTAL

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

Interventions

Acupuncture plus morphine PROCEDURE

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

Left PVI ablation electroacupuncture group; Right PVI ablation electroacupuncture group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old;
• Atrial fibrillation
• Nonresponse or intolerance to ≥1 antiarrhythmic drug.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Acupuncture Therapy; Morphine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, deputy director of cardiology department of Shanghai Chest Hospital

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 12, 2022
• Study Start: October 11, 2022
• Primary Completion: October 11, 2023
• Study Completion: October 13, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10