Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Sponsor

Shanghai Chest Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05575544

Collaborator

(none)

200

Enrollment

Arms

12.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Catheter Ablation	Procedure: Acupuncture plus morphine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Oct 11, 2022

Anticipated Primary Completion Date :

Oct 11, 2023

Anticipated Study Completion Date :

Oct 13, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Chest Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu Liu, Professor, deputy director of cardiology department of Shanghai Chest Hospital, Shanghai Chest Hospital

ClinicalTrials.gov Identifier:

NCT05575544

Other Study ID Numbers:

EAAF

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 12, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Morphine

Study Results

No Results Posted as of Oct 12, 2022