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Completed

NCT Number: NCT05397886

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

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.

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Key information

Conditions

Recovery

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam besylate

Drug

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

Drug

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

Propofol

Drug

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.

Primary outcomes

  1. Time to eye opening

    Time frame: up to 1 hour

    Time to first eye opening responding to doctor's command from discontinuation of main anesthetics

Secondary outcomes

  1. Time to remove laryngeal mask airway

    Time frame: up to 1 hour

    Time to removal of supraglottic laryngeal mask airway from discontinuation of main anesthetics

  2. Incidence of hypotension

    Time frame: 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

  3. Vasoactive-inotropic score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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