Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 (DenoganĀ®, 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propacetamol group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propacetamol | Drug | Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | 1 day | |
| Depth of sedation | depth of sedation measured by Ramsay Sedation Score | 1 day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C063776 | propacetamol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure. |
|
|
| 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 |