Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05575544
• Other study ID #: EAAF
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 13, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation

Intervention

Procedure:
• Acupuncture plus morphine
The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Change of the the radio of IL6/IL10 before and after the ablation procedure		up to 1 months after enrollment
Secondary	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