Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Remimazolam With Flumazenil vs. Propofol TIVA During RFCA for Atrial Fibrillation

Conditions
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Recovery

Intervention / Treatment
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* Drug: Remimazolam Besylate
* Drug: Flumazenil
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam with flumazenil<br>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. | Drug: Remimazolam Besylate<br>* 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.<br>Drug: Flumazenil<br>* Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.<br>|
| Active Comparator: Propofol total intravenous anesthesia<br>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. | Drug: Propofol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to eye opening | Time to first eye opening responding to doctor's command from discontinuation of main anesthetics | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to remove laryngeal mask airway | Time to removal of supraglottic laryngeal mask airway from discontinuation of main anesthetics | 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 | 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) | During anesthesia for radiofrequency ablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recovery, remimazolam, flumazenil, propofol, radiofrequency catheter ablation