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Completed

NCT Number: NCT02515188

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.

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propacetamol

Drug

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)

Placebo

Drug

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

Other names: Normal Saline

Primary outcomes

  1. total amount of opioid consumption

    Time frame: 1 day

    Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.

Secondary outcomes

  1. Respiratory rate

    Time frame: 1 day

  2. Depth of sedation

    Time frame: 1 day

    depth of sedation measured by Ramsay Sedation Score

  3. Post procedural pain

    Time frame: 1 day

    post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)

  4. nausea point

    Time frame: 1 day

    nausea measured by 11-point NRS (Numerical Rating Scale)

  5. number of vomiting

    Time frame: 1 day

  6. intra-procedural hemodynamics

    Time frame: 1 day

    intra-procedural hemodynamics measured by amount of used vasopressors

  7. satisfaction of patients

    Time frame: 1 day

    satisfaction of patient and surgeons measured by 5-point NRS

  8. recovery time

    Time frame: 1 day

    monitored with heart rate and blood pressure

  9. satisfaction of surgeons

    Time frame: 1 day

    satisfaction of patient and surgeons measured by 5-point NRS

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2015
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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