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

NCT ID: NCT02515188

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-07
• Study Completion Date: 2016-06-23

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.

Conditions

Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

propacetamol group

Group Type: EXPERIMENTAL

Propacetamol

Intervention Type: DRUG

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

placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Propacetamol

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Propacetamol (Denogan®, Yungjin, Seoul, Korea); Normal Saline

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2015-0502

Identifier Type: -

Identifier Source: org_study_id