MedTrace Logo

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

NCT02515188 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-01-28

No results posted yet for this study

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

DRUG

Propacetamol

Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.

DRUG

Placebo

Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-07
Primary Completion
2016-06-23
Completion
2016-06-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515188 on ClinicalTrials.gov