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

Seoul National University

Status: Completed

Conditions: Recovery

Treatments: Drug: Flumazenil; Drug: Propofol; Drug: Remimazolam Besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05397886

Remimazolam_RFCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Remimazolam with flumazenil

Experimental group

Description:

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.

Treatment:

Drug: Flumazenil

Drug: Remimazolam Besylate

Propofol total intravenous anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol