Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation
NCT ID: NCT05397886
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
54 participants
INTERVENTIONAL
2022-08-02
2023-04-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Remimazolam with flumazenil
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.
Remimazolam Besylate
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.
Flumazenil
Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.
Propofol total intravenous anesthesia
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.
Propofol
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remimazolam Besylate
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.
Flumazenil
Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.
Propofol
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yunseok Jeon
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yunseok Jeon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Remimazolam_RFCA
Identifier Type: -
Identifier Source: org_study_id