The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
- Registration Number
- NCT02515188
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- patients who are scheduled to undergo catheter ablation for arrhythmia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description propacetamol group Propacetamol - placebo group Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Respiratory rate 1 day 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 intra-procedural hemodynamics 1 day intra-procedural hemodynamics measured by amount of used vasopressors
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
Trial Locations
- Locations (1)
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of