RecoveryNCT05397886
Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation
A study testing Remimazolam Besylate, Flumazenil and Propofol in people with Recovery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol total intravenous anesthesia as the main general anesthetics during radiofrequency catheter ablation treatment of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Recovery
- What is being tested?
- Remimazolam Besylate, Flumazenil and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2022to 25 Apr 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia
Who cannot join
- Patients who are not alert before procedure
- Hemodynamicaly unstable patients before procedure
- Patients with history of adverse reaction of allergic reaction to study drugs
- Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support
- Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h
- Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
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- Severe hepatic or renal dysfunction
- Alcohol or drug dependence
- Organic brain disorder
- Spinal or cerebellar ataxia
- Acute narrow-angle glaucoma
- Patients with shock or coma
- Pregnant or lactating women
- Patients with hypersensitive to beans or peanut
- Patients who refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Remimazolam With Flumazenil vs. Propofol TIVA During RFCA for Atrial Fibrillation
This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol total intravenous anesthesia as the main general anesthetics during radiofrequency catheter ablation treatment of atrial fibrillation.
Read the detailed description
Adult patients with atrial fibrillation undergoing radiofrequency catheter ablation under general anesthesia are randomized to receive either remimazolam with flumazenil or propofol total intravenous anesthesia as the main anesthetics. After completion of radiofrequency ablation, each anesthetic is discontinued. The primary outcome of the study is comparison of the time to the first eye opening responding to doctor's command from the discontinuation of each drug between the groups. Secondary outcomes includes the time to removal of supraglottic laryngeal mask airway device from discontinuation of each drug, incidence of three consecutive hypotension (systolic blood pressure under 80 mmHg) recordings at 2.5 min-intervals, and intraprocedural vasoactive-inotropic score.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
Remimazolam Besylate is used as intervention drug for general anesthesia, which followed by flumazenil administration at the end of anesthesia, to be compared to propofol total intravenous anesthesia during radiofrequency catheter ablation of atrial fibrillation.
FlumazenilDrug
Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.
PropofolDrug
Propofol is used as active comparator drug for general anesthesia until the end of anesthesia, to be compared to remimazolam besylate during radiofrequency catheter ablation of atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam with flumazenil | Experimental | Patients allocated to remimazolam with flumazenil group receives remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia. Receives: Drug: Remimazolam Besylate; Drug: Flumazenil |
| Propofol total intravenous anesthesia | Active comparator | Patients allocated to propofol total intravenous anesthesia group receives propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to eye opening
Time to first eye opening responding to doctor's command from discontinuation of main anesthetics
Measured: up to 1 hour
Secondary outcomes (3)
Time to remove laryngeal mask airway
Time to removal of supraglottic laryngeal mask airway from discontinuation of main anesthetics
Measured: up to 1 hour
Incidence of hypotension
Incidence of three consecutive hypotension, which is defined as systolic blood pressure under 80 mmHg, at 2.5 min-intervals
Measured: During anesthesia for radiofrequency ablation procedure
Vasoactive-inotropic score
Intraprocedural vasoactive-inotropic score, which is calculated as: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 х epinephrine (μg/kg/min) + 100 х norepinephrine (μg/kg/min) + 10000 х vasopressin (unit/kg/min)
Measured: During anesthesia for radiofrequency ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start2 Aug 2022
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecoveryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397886
- Sponsor's protocol ID
- Remimazolam_RFCA
- Status last verified
- Nov 2023
- First submitted
- 9 May 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Lee J, Hwang SY, Ju JW, Nam K, Ahn HJ, Lee SR, Choi EK, Jeon Y, Cho YJ. Remimazolam-flumazenil provides fast recovery from general anesthesia compared to propofol during radiofrequency catheter ablation of atrial fibrillation. Sci Rep. 2024 Jun 3;14(1):12660. doi: 10.1038/s41598-024-63578-8.
PubMed 38831029
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam With Flumazenil vs. Propofol TIVA During RFCA for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05397886
- Acronym / sponsor ID
- Remimazolam_RFCA
- Conditions
- Recovery
- Keywords
- recovery, remimazolam, flumazenil, propofol, radiofrequency catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 31 May 2022 (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.
This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol total intravenous anesthesia as the main general anesthetics during radiofrequency catheter ablation treatment of atrial fibrillation.
Detailed description
Adult patients with atrial fibrillation undergoing radiofrequency catheter ablation under general anesthesia are randomized to receive either remimazolam with flumazenil or propofol total intravenous anesthesia as the main anesthetics. After completion of radiofrequency ablation, each anesthetic is discontinued. The primary outcome of the study is comparison of the time to the first eye opening responding to doctor's command from the discontinuation of each drug between the groups. Secondary outcomes includes the time to removal of supraglottic laryngeal mask airway device from discontinuation of each drug, incidence of three consecutive hypotension (systolic blood pressure under 80 mmHg) recordings at 2.5 min-intervals, and intraprocedural vasoactive-inotropic score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam with flumazenil | Experimental | Drug: Remimazolam Besylate, Drug: FlumazenilPatients allocated to remimazolam with flumazenil group receives remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia. |
| Propofol total intravenous anesthesia | Active comparator | Drug: PropofolPatients allocated to propofol total intravenous anesthesia group receives propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia
Key exclusion criteria (15 listed)
- Patients who are not alert before procedure
- Hemodynamicaly unstable patients before procedure
- Patients with history of adverse reaction of allergic reaction to study drugs
- Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support
- Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h
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 BesylateRemimazolam Besylate is used as intervention drug for general anesthesia, which followed by flumazenil administration at the end of anesthesia, to be compared to propofol total intravenous anesthesia during radiofrequency catheter ablation of atrial fibrillation. | Drug | Remimazolam with flumazenil |
| FlumazenilFlumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group. | Drug | Remimazolam with flumazenil |
| PropofolPropofol is used as active comparator drug for general anesthesia until the end of anesthesia, to be compared to remimazolam besylate during radiofrequency catheter ablation of atrial fibrillation. | Drug | Propofol total intravenous anesthesia |
Primary outcome
Time to eye opening
Time frame: up to 1 hour
Time to first eye opening responding to doctor's command from discontinuation of main anesthetics
3 secondary outcomes
Time to remove laryngeal mask airway
Time frame: up to 1 hour
Incidence of hypotension
Time frame: During anesthesia for radiofrequency ablation procedure
Vasoactive-inotropic score
Time frame: During anesthesia for radiofrequency ablation procedure
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 22 Nov 2023.
- Derived from this study: PubMed 38831029Lee S, Lee J, Hwang SY, Ju JW, Nam K, Ahn HJ, Lee SR, Choi EK, Jeon Y, Cho YJ. Remimazolam-flumazenil provides fast recovery from general anesthesia compared to propofol during radiofrequency catheter ablation of atrial fibrillation. Sci Rep. 2024 Jun 3;14(1):12660. doi: 10.1038/s41598-024-63578-8.
- Individual participant dataSharing planned: Undecided
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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.
Yunseok Jeon, MD, PhD principal investigator
Seoul National University Hospital
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 Besylate, Flumazenil and Propofol in people with Recovery, run by Seoul National University Hospital 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 15 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 22 Nov 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?
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?
Time to eye opening (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397886, which also lists 1 linked publication.
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 22 Nov 2023.