Clinical trial NCT05397886: Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation
Official title: Comparison of Remimazolam With Flumazenil vs. Propofol TIVA During RFCA for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery
Keywords: recovery
remimazolam
flumazenil
propofol
radiofrequency catheter ablation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to eye opening
timeFrame: up to 1 hour
Secondary outcomes:
measure: Time to remove laryngeal mask airway
timeFrame: up to 1 hour
measure: Incidence of hypotension
timeFrame: During anesthesia for radiofrequency ablation procedure
measure: Vasoactive-inotropic score
timeFrame: During anesthesia for radiofrequency ablation procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: