Recovery
Conditions
Keywords
recovery, remimazolam, flumazenil, propofol, radiofrequency catheter ablation
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.
Interventions
DRUGRemimazolam 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.
DRUGFlumazenil
Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.
DRUGPropofol
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to eye opening | up to 1 hour | Time to first eye opening responding to doctor's command from discontinuation of main anesthetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to remove laryngeal mask airway | up to 1 hour | Time to removal of supraglottic laryngeal mask airway from discontinuation of main anesthetics |
| Incidence of hypotension | During anesthesia for radiofrequency ablation procedure | Incidence of three consecutive hypotension, which is defined as systolic blood pressure under 80 mmHg, at 2.5 min-intervals |
| Vasoactive-inotropic score | During anesthesia for radiofrequency ablation procedure | 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) |
Countries
South Korea
Outcome results
None listed