The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.

Study Overview
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Brief Summary
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Sedation for catheter ablation of atrial fibrillation should be performed to achieve analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However, propofol and midazolam causes respiratory depression and dexmedetomidine occasionally accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that does not induce respiratory depression with stable hemodynamics is needed. Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators hypothesized that addition of propacetamol to previously used sedatives midazolam-remifentanil will reduce opioid consumption during the catheter ablation. Therefore, the investigators designed this study to investigate the role of addition of propacetamol to previous used midazolam-remifentanil sedation. This study will compare the opioid consumption and respiratory effect of propacetamol with placebo-control for catheter ablation of atrial fibrillation.

Conditions
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Arrhythmia

Intervention / Treatment
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* Drug: Propacetamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are scheduled to undergo catheter ablation for arrhythmia Exclusion Criteria: Subjects are ineligible if they have liver disease, kidney disease, American society of anesthesiology class 3 or 4, age under 20 years, cognitive dysfunction, disabling mental change disorder, patients are unable to communicate or speak Korean

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propacetamol group<br> | Drug: Propacetamol<br>* Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.<br>* Other names: Propacetamol (Denogan®, Yungjin, Seoul, Korea);|
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total amount of opioid consumption | Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate |  | 1 day | 
| Depth of sedation | depth of sedation measured by Ramsay Sedation Score | 1 day | 
| Post procedural pain | post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale) | 1 day | 
| nausea point | nausea measured by 11-point NRS (Numerical Rating Scale) | 1 day | 
| number of vomiting |  | 1 day | 
| intra-procedural hemodynamics | intra-procedural hemodynamics measured by amount of used vasopressors | 1 day | 
| satisfaction of patients | satisfaction of patient and surgeons measured by 5-point NRS | 1 day | 
| recovery time | monitored with heart rate and blood pressure | 1 day | 
| satisfaction of surgeons | satisfaction of patient and surgeons measured by 5-point NRS | 1 day |