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

Arrhythmia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515188
• Other study ID #: 4-2015-0502
• Status: Completed
• Phase: N/A
• Start date: August 7, 2015
• Est. completion date: June 23, 2016

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 23, 2016
• Est. primary completion date: June 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Drug:
• Propacetamol
Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
• Placebo
Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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