Atrial Fibrillation, Catheter Ablation
Conditions
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.
Interventions
PROCEDUREAcupuncture plus morphine
The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Outcome results
None listed