Clinical Trials Directory

Trials / Completed

CompletedNCT02515188

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
20 Years – 79 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPropacetamolRandomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
DRUGPlaceboPlacebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.

Timeline

Start date
2015-08-07
Primary completion
2016-06-23
Completion
2016-06-23
First posted
2015-08-04
Last updated
2019-01-28

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02515188. Inclusion in this directory is not an endorsement.