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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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To evaluate the efficacy and safety of intravenous lidocaine in reducing diaphragmatic contraction and suppressing the cough reflex during pulsed field ablation procedures.
Atrial fibrillation is a common arrhythmia, and pulmonary vein isolation is the main treatment. The emerging pulsed field ablation (PFA) is tissue-selective and can reduce damage to adjacent organs, but it is often accompanied by phrenic nerve stimulation and cough reflex, affecting surgical stability. Intravenous lidocaine has been shown to suppress cough and hiccups, but its effect on PFA-induced responses has not been further studied. This study uses a prospective, randomized controlled trial to evaluate the effects of lidocaine on diaphragmatic contraction and cough reflex during PFA surgery, aiming to improve surgical safety and procedural smoothness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIDOCAINE | Experimental | Lidocaine 1 mg/kg |
|
| Saline | Active Comparator | Saline 3~5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine | Drug | baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression. | The reduction of diaphragm contraction and dry cough frequency and intensity;
| 400 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute effect (per vein) |
| 400DAYS |
| Chronic effect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chih-Chieh Yu, MD.PhD | Contact | 0972652038 | sweetchieh@gmail.com | |
| HSIAO-HAN HUANG | Contact | 0932917553 | clrhuang8853@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospita | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Aims: To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression.
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| Saline | Drug | baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection |
|
The AF recurrence rate within 1 year after the index procedure. |
| 400DAYS |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |