ArrhythmiaNCT02515188
The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
A study testing Propacetamol in people with Arrhythmia, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Propacetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2015to 23 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are scheduled to undergo catheter ablation for arrhythmia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
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
- Being tested
- Propacetamol, Placebo
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropacetamolDrug
Also called Propacetamol (Denogan®, Yungjin, Seoul, Korea)
Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
PlaceboDrug
Also called Normal Saline
Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| propacetamol group | Experimental | Not described Receives: Drug: Propacetamol |
| placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of opioid consumption
Total opioid consumption during the procedure will be recorded. And post procedural consumption of analgesics also will be recorded.
Measured: 1 day
Secondary outcomes (9)
Respiratory rate
Measured: 1 day
Depth of sedation
depth of sedation measured by Ramsay Sedation Score
Measured: 1 day
Post procedural pain
post procedural pain measured by consumption of analgesics and VAS (Visual Analog Scale)
Measured: 1 day
nausea point
nausea measured by 11-point NRS (Numerical Rating Scale)
Measured: 1 day
number of vomiting
Measured: 1 day
intra-procedural hemodynamics
intra-procedural hemodynamics measured by amount of used vasopressors
Measured: 1 day
satisfaction of patients
satisfaction of patient and surgeons measured by 5-point NRS
Measured: 1 day
recovery time
monitored with heart rate and blood pressure
Measured: 1 day
satisfaction of surgeons
satisfaction of patient and surgeons measured by 5-point NRS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study start7 Aug 2015
- Primary completion23 Jun 2016
- Study completion23 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515188
- Sponsor's protocol ID
- 4-2015-0502
- Status last verified
- Jan 2019
- First submitted
- 30 Jul 2015
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT02515188
- Acronym / sponsor ID
- 4-2015-0502
- Conditions
- Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Aug 2015 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 23 Jun 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propacetamol group | Experimental | Drug: Propacetamol |
| placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who are scheduled to undergo catheter ablation for arrhythmia
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropacetamolAlso: Propacetamol (Denogan®, Yungjin, Seoul, Korea)Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure. | Drug | propacetamol group |
| PlaceboAlso: Normal SalinePlacebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure. | Drug | placebo group |
Primary outcome
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.
9 secondary outcomes
Respiratory rate
Time frame: 1 day
Depth of sedation
Time frame: 1 day
Post procedural pain
Time frame: 1 day
nausea point
Time frame: 1 day
number of vomiting
Time frame: 1 day
intra-procedural hemodynamics
Time frame: 1 day
satisfaction of patients
Time frame: 1 day
recovery time
Time frame: 1 day
satisfaction of surgeons
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propacetamol in people with Arrhythmia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total amount of opioid consumption (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.