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

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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

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

Trial contacts and locations

1

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Central trial contact

Youn Joung Cho, MD, PhD; Yunseok Jeon, MD, PhD

Data sourced from clinicaltrials.gov

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