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

NCT05397886 | Completed DMC

• 1 other identifier: Remimazolam_RFCA
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Recovery

Keywords

recovery; remimazolam; flumazenil; propofol; radiofrequency catheter ablation

Outcome Measures

Primary Outcomes (1)

• Time to eye opening

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

  up to 1 hour

Secondary Outcomes (3)

• Time to remove laryngeal mask airway

  up to 1 hour

• Incidence of hypotension

  During anesthesia for radiofrequency ablation procedure

• Vasoactive-inotropic score

  During anesthesia for radiofrequency ablation procedure

Study Arms (2)

Remimazolam with flumazenil

EXPERIMENTAL

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.

Drug: Remimazolam Besylate; Drug: Flumazenil

Propofol total intravenous anesthesia

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

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.

Remimazolam with flumazenil

Flumazenil DRUG

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

Remimazolam with flumazenil

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.

Propofol total intravenous anesthesia

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Lee S, Lee J, Hwang SY, Ju JW, Nam K, Ahn HJ, Lee SR, Choi EK, Jeon Y, Cho YJ. Remimazolam-flumazenil provides fast recovery from general anesthesia compared to propofol during radiofrequency catheter ablation of atrial fibrillation. Sci Rep. 2024 Jun 3;14(1):12660. doi: 10.1038/s41598-024-63578-8.

  PMID: 38831029 DERIVED

MeSH Terms

Interventions

Flumazenil; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yunseok Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 31, 2022
• Study Start: August 2, 2022
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

KR (1)