An interventional study of Propacetamol and Placebo in Arrhythmia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 98 is close to the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Drug: Propacetamol
Drug: Placebo
Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
Also known as: Propacetamol (Denogan®, Yungjin, Seoul, Korea)
Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
Also known as: Normal Saline
total amount of opioid consumption
Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.
Time frame: 1 day
Respiratory rate
Time frame: 1 day
Depth of sedation
depth of sedation measured by Ramsay Sedation Score
Time frame: 1 day
Post procedural pain
post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)
Time frame: 1 day
nausea point
nausea measured by 11-point NRS (Numerical Rating Scale)
Time frame: 1 day
number of vomiting
Time frame: 1 day
intra-procedural hemodynamics
intra-procedural hemodynamics measured by amount of used vasopressors
Time frame: 1 day
satisfaction of patients
satisfaction of patient and surgeons measured by 5-point NRS
Time frame: 1 day
recovery time
monitored with heart rate and blood pressure
Time frame: 1 day
satisfaction of surgeons
satisfaction of patient and surgeons measured by 5-point NRS
Time frame: 1 day
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Yonsei University