Arrhythmia
Conditions
Brief summary
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.
Interventions
DRUGPropacetamol
Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
DRUGPlacebo
Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total amount of opioid consumption | 1 day | Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depth of sedation | 1 day | depth of sedation measured by Ramsay Sedation Score |
| Post procedural pain | 1 day | post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale) |
| nausea point | 1 day | nausea measured by 11-point NRS (Numerical Rating Scale) |
| number of vomiting | 1 day | — |
| Respiratory rate | 1 day | — |
| satisfaction of patients | 1 day | satisfaction of patient and surgeons measured by 5-point NRS |
| recovery time | 1 day | monitored with heart rate and blood pressure |
| satisfaction of surgeons | 1 day | satisfaction of patient and surgeons measured by 5-point NRS |
| intra-procedural hemodynamics | 1 day | intra-procedural hemodynamics measured by amount of used vasopressors |
Countries
South Korea
Outcome results
None listed