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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Drug: Propacetamol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Drug: Placebo; Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.; Other Names: Normal Saline
Experimental: propacetamol group	Drug: Propacetamol; Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.; Other Names: Propacetamol (Denogan®, Yungjin, Seoul, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total amount of opioid consumption	Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate		1 day
Depth of sedation	depth of sedation measured by Ramsay Sedation Score	1 day
Post procedural pain	post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)	1 day
nausea point	nausea measured by 11-point NRS (Numerical Rating Scale)	1 day
number of vomiting		1 day
intra-procedural hemodynamics	intra-procedural hemodynamics measured by amount of used vasopressors	1 day
satisfaction of patients	satisfaction of patient and surgeons measured by 5-point NRS	1 day
recovery time	monitored with heart rate and blood pressure	1 day
satisfaction of surgeons	satisfaction of patient and surgeons measured by 5-point NRS	1 day

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2015
• Primary Completion (Actual): June 23, 2016
• Study Completion (Actual): June 23, 2016

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Acetaminophen; Propacetamol
• Other Study ID Numbers: 4-2015-0502