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

Not Applicable

Completed

• Conditions: Recovery
• Interventions: Drug: Remimazolam Besylate; Drug: Propofol; Drug: Flumazenil

• Registration Number: NCT05397886
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-05-31
• Study Start: 2022-08-02
• Primary Completion: 2023-04-25
• Study Completion: 2023-04-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam with flumazenil	Remimazolam Besylate	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.
Remimazolam with flumazenil	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.
Propofol total intravenous anesthesia	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Time to eye opening	up to 1 hour	Time to first eye opening responding to doctor's command from discontinuation of main anesthetics

Secondary Outcome Measures

Name	Time	Method
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)
Time to remove laryngeal mask airway	up to 1 hour	Time to removal of supraglottic laryngeal mask airway from discontinuation of main anesthetics

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of