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

Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397886
• Other study ID #: Remimazolam_RFCA
• Status: Completed
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: April 25, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recovery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to eye opening	Time to first eye opening responding to doctor's command from discontinuation of main anesthetics	up to 1 hour
Secondary	Time to remove laryngeal mask airway	Time to removal of supraglottic laryngeal mask airway from discontinuation of main anesthetics	up to 1 hour
Secondary	Incidence of hypotension	Incidence of three consecutive hypotension, which is defined as systolic blood pressure under 80 mmHg, at 2.5 min-intervals	During anesthesia for radiofrequency ablation procedure
Secondary	Vasoactive-inotropic score	Intraprocedural vasoactive-inotropic score, which is calculated as: dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 ? epinephrine (µg/kg/min) + 100 ? norepinephrine (µg/kg/min) + 10000 ? vasopressin (unit/kg/min)	During anesthesia for radiofrequency ablation procedure