Comparison of Remimazolam With Flumazenil vs. Propofol TIVA During RFCA for Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Remimazolam Besylate
- Conditions
- Recovery
- Sponsor
- Seoul National University Hospital
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Time to eye opening
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
Investigators
Yunseok Jeon
Professor
Seoul National University Hospital
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Remimazolam Besylate
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.
Intervention: Flumazenil
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.
Intervention: Propofol
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Incidence of hypotension(During anesthesia for radiofrequency ablation procedure)
- Vasoactive-inotropic score(During anesthesia for radiofrequency ablation procedure)
- Time to remove laryngeal mask airway(up to 1 hour)