Back to resultsThe Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
Primary Purpose
Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propacetamol
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Arrhythmia
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
Sites / Locations
- Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
propacetamol group
placebo group
Arm Description
Outcomes
Primary Outcome Measures
total amount of opioid consumption
Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.
Secondary Outcome Measures
Respiratory rate
Depth of sedation
depth of sedation measured by Ramsay Sedation Score
Post procedural pain
post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)
nausea point
nausea measured by 11-point NRS (Numerical Rating Scale)
number of vomiting
intra-procedural hemodynamics
intra-procedural hemodynamics measured by amount of used vasopressors
satisfaction of patients
satisfaction of patient and surgeons measured by 5-point NRS
recovery time
monitored with heart rate and blood pressure
satisfaction of surgeons
satisfaction of patient and surgeons measured by 5-point NRS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02515188
Brief Title
The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2015 (Actual)
Primary Completion Date
June 23, 2016 (Actual)
Study Completion Date
June 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propacetamol group
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propacetamol
Other Intervention Name(s)
Propacetamol (Denogan®, Yungjin, Seoul, Korea)
Intervention Description
Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
Primary Outcome Measure Information:
Title
total amount of opioid consumption
Description
Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Respiratory rate
Time Frame
1 day
Title
Depth of sedation
Description
depth of sedation measured by Ramsay Sedation Score
Time Frame
1 day
Title
Post procedural pain
Description
post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)
Time Frame
1 day
Title
nausea point
Description
nausea measured by 11-point NRS (Numerical Rating Scale)
Time Frame
1 day
Title
number of vomiting
Time Frame
1 day
Title
intra-procedural hemodynamics
Description
intra-procedural hemodynamics measured by amount of used vasopressors
Time Frame
1 day
Title
satisfaction of patients
Description
satisfaction of patient and surgeons measured by 5-point NRS
Time Frame
1 day
Title
recovery time
Description
monitored with heart rate and blood pressure
Time Frame
1 day
Title
satisfaction of surgeons
Description
satisfaction of patient and surgeons measured by 5-point NRS
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
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