Patients With Atrial Fibrillation Undergoing Catheter AblationNCT05864404
Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation
A study testing remimazolam-remifentanil and dexmedetomidine-remifentanil in people with Patients With Atrial Fibrillation Undergoing Catheter Ablation, run by Yonsei University at 1 site in South Korea.
Trial summary
The primary purpose of this study was to investigate whether remimazolam administration for sedation had a positive effect on patients' satisfaction compared to dexmedetomidine administration in patients with atrial fibrillation undergoing catheter ablation. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Patients With Atrial Fibrillation Undergoing Catheter Ablation
- What is being tested?
- remimazolam-remifentanil and dexmedetomidine-remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2023to 9 Oct 2024
- 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
- Age 20-79 years, gender not limited
- Patients undergoing catheter ablation for atrial fibrillation who require monitored anesthetic care (MAC).
- Patients with an American Society of Anesthesiologists (ASA) physical status classification 1,2,3.
Who cannot join
- Patients with an American Society of Anesthesiologists (ASA) physical status classification >3.
- Patients with a history of psychiatric disorders
- Patients with myocardial infarction or stroke within the past year
- Patients with a history of major vascular surgery or cardiac surgery within the past year
- Patients with reduced liver function, chronic kidney disease (stage 3 or higher)
- Patients diagnosed with heart failure with a left ventricular ejection fraction <40%
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- Patients who need vasopressor or oxygen therapy due to unstable vital signs before procedure.
- Patients with fever (>38°) or severe uncontrolled high blood pressure
- Patients with a history of drug hypersensitivity during previous anesthesia
- Patients who are unable to communicate and have cognitive impairment
- Patients with a history of drug or alcohol addiction
- Patients with a history of obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul
Sarah Soh, 82-2-2228-8512, yeonchoo@yuhs.ac
About this study
The primary purpose of this study was to investigate whether remimazolam administration for sedation had a positive effect on patients' satisfaction compared to dexmedetomidine administration in patients with atrial fibrillation undergoing catheter ablation.
Atrial fibrillation is a common arrhythmia in clinical practice. Catheter ablation can be used when the cause of atrial fibrillation is in the pulmonary veins. However, the procedure takes 2 to 4 hours, and patients complain of considerable discomfort. Remimazolam has the advantage of having no drug interaction with CYP3A4 and shorter elimination half-life, duration of action, and shorter recovery time than midazolam, a previously used drug. In addition, compared to dexmedetomidine, side effects such as bradycardia and hypotension are expected to be less. In addition, even if unexpected deep sedation is induced, complete reversal using flumazenil is possible, so the risk of re-sedation could be low.
In other words, when remimazolam is used instead of a drug previously used as a sedative in atrial fibrillation patients undergoing catheter ablation, effects such as rapid action and recovery, reduced complications, improved safety, and improved patient satisfaction can be expected. Therefore, this study was designed to confirm the hypothesis that administration of remimazolam would improve satisfaction in patients undergoing catheter ablation compared to dexmedetomidine.
- Being tested
- remimazolam-remifentanil, dexmedetomidine-remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam-remifentanilDrug
In the case of remimazolam, the bolus is prepared in a 30cc syringe by mixing 0.075mg/kg and normal saline to make a total of 25mL. Inject the bolus at a rate of 150 cc/h, and measure the sedation depth every 2 to 3 minutes, stopping the infusion when the target sedation depth (RASS -1 to -2 points) is reached. Remimazolam is then infused at 0.5 to 1 mg/kg/hr to maintain the target depth of sedation until the end of the procedure. Remifentanil was infused at a rate of 1.2-7.2 mcg/kg/h.
dexmedetomidine-remifentanilDrug
In the case of dexmedetomidine, the bolus is prepared in a 30cc syringe by mixing 1.0mcg/kg and normal saline to make a total of 25mL. Inject the bolus at a rate of 150 cc/h, and measure the sedation depth every 2 to 3 minutes, stopping the infusion when the target sedation depth (RASS -1 to -2 points) is reached. Dexmedetomidine is then infused at 0.4 to 0.8 mcg/kg/h to maintain the target depth of sedation until the end of the procedure. Remifentanil was infused at a rate of 1.2-7.2 mcg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| remimazolam-remifentanil (RR group) | Experimental | Not described Receives: Drug: remimazolam-remifentanil |
| dexmedetomidine-remifentanil (DR group) | Active comparator | Not described Receives: Drug: dexmedetomidine-remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The satisfaction levels of the patients
The satisfaction levels of the patients was assessed with a 5-point numerical scale (0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied).
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start24 May 2023
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Atrial Fibrillation Undergoing Catheter AblationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864404
- Sponsor's protocol ID
- 4-2023-0173
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation
- ClinicalTrials.gov ID
- NCT05864404
- Acronym / sponsor ID
- 4-2023-0173
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 18 May 2023 (actual)
- 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.
The primary purpose of this study was to investigate whether remimazolam administration for sedation had a positive effect on patients' satisfaction compared to dexmedetomidine administration in patients with atrial fibrillation undergoing catheter ablation.
Atrial fibrillation is a common arrhythmia in clinical practice. Catheter ablation can be used when the cause of atrial fibrillation is in the pulmonary veins. However, the procedure takes 2 to 4 hours, and patients complain of considerable discomfort. Remimazolam has the advantage of having no drug interaction with CYP3A4 and shorter elimination half-life, duration of action, and shorter recovery time than midazolam, a previously used drug. In addition, compared to dexmedetomidine, side effects such as bradycardia and hypotension are expected to be less. In addition, even if unexpected deep sedation is induced, complete reversal using flumazenil is possible, so the risk of re-sedation could be low.
In other words, when remimazolam is used instead of a drug previously used as a sedative in atrial fibrillation patients undergoing catheter ablation, effects such as rapid action and recovery, reduced complications, improved safety, and improved patient satisfaction can be expected. Therefore, this study was designed to confirm the hypothesis that administration of remimazolam would improve satisfaction in patients undergoing catheter ablation compared to dexmedetomidine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam-remifentanil (RR group) | Experimental | Drug: remimazolam-remifentanil |
| dexmedetomidine-remifentanil (DR group) | Active comparator | Drug: dexmedetomidine-remifentanil |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-79 years, gender not limited
- Patients undergoing catheter ablation for atrial fibrillation who require monitored anesthetic care (MAC).
- Patients with an American Society of Anesthesiologists (ASA) physical status classification 1,2,3.
Key exclusion criteria (12 listed)
- Patients with an American Society of Anesthesiologists (ASA) physical status classification >3.
- Patients with a history of psychiatric disorders
- Patients with myocardial infarction or stroke within the past year
- Patients with a history of major vascular surgery or cardiac surgery within the past year
- Patients with reduced liver function, chronic kidney disease (stage 3 or higher)
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 |
|---|---|---|
| remimazolam-remifentanilIn the case of remimazolam, the bolus is prepared in a 30cc syringe by mixing 0.075mg/kg and normal saline to make a total of 25mL. Inject the bolus at a rate of 150 cc/h, and measure the sedation depth every 2 to 3 minutes, stopping the infusion when the target sedation depth (RASS -1 to -2 points) is reached. Remimazolam is then infused at 0.5 to 1 mg/kg/hr to maintain the target depth of sedation until the end of the procedure. Remifentanil was infused at a rate of 1.2-7.2 mcg/kg/h. | Drug | remimazolam-remifentanil (RR group) |
| dexmedetomidine-remifentanilIn the case of dexmedetomidine, the bolus is prepared in a 30cc syringe by mixing 1.0mcg/kg and normal saline to make a total of 25mL. Inject the bolus at a rate of 150 cc/h, and measure the sedation depth every 2 to 3 minutes, stopping the infusion when the target sedation depth (RASS -1 to -2 points) is reached. Dexmedetomidine is then infused at 0.4 to 0.8 mcg/kg/h to maintain the target depth of sedation until the end of the procedure. Remifentanil was infused at a rate of 1.2-7.2 mcg/kg/h. | Drug | dexmedetomidine-remifentanil (DR group) |
Primary outcome
The satisfaction levels of the patients
Time frame: Immediately after the procedure
The satisfaction levels of the patients was assessed with a 5-point numerical scale (0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Patients With Atrial Fibrillation Undergoing Catheter Ablation
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RecruitingObservational study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam-remifentanil and dexmedetomidine-remifentanil in people with Patients With Atrial Fibrillation Undergoing Catheter Ablation, 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Soh (82-2-2228-8512, yeonchoo@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The satisfaction levels of the patients (time frame: Immediately after the procedure). 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 30 May 2023.