NCT05397886

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recovery

Interventions

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

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2022-05-31
• Last updated: 2023-11-22

Locations

1 site across 1 country: South Korea