Clinical trial

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

Name

Remimazolam_RFCA

Description

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.

Trial arms

Trial start

2022-08-02

Estimated PCD

2023-04-25

Trial end

2023-04-25

Status

Completed

Treatment

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.

Arms:

Remimazolam with flumazenil

Flumazenil

Flumazenil is used as additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.

Arms:

Remimazolam with flumazenil

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.

Arms:

Propofol total intravenous anesthesia

Size

Primary endpoint

Time to eye opening

up to 1 hour

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 * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

Updated at

2023-11-22

1 organization

3 products

1 indication

Organization

Seoul National University Hospital

Product

Indication

Product

Product