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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
60
National Taiwan University Hospita
Taipei, Taiwan
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; 1. the diaphragm movement distance during ablation, evaluated with intracardiac echocardiography (ICE); 2. the cough frequency and intensity after energy application; cough frequency will be evaluated by a blinded technician, and cough intensity will be evaluated by both the technician and ICE;
Time frame: 400 days
Acute effect (per vein)
1. the number of ablations that has to be terminated prematurely; 2. the extra number of ablations that has to be applied to achieve entry block; 3. the need to remap (3D electroanatomical map shifting);
Time frame: 400DAYS
Chronic effect
The AF recurrence rate within 1 year after the index procedure.
Time frame: 400DAYS
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