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

Primary Purpose

Recovery

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remimazolam Besylate

Flumazenil

Propofol

About this trial

This is an interventional treatment trial for Recovery focused on measuring recovery, remimazolam, flumazenil, propofol, radiofrequency catheter ablation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam with flumazenil

Propofol total intravenous anesthesia

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time to eye opening

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

Secondary Outcome Measures

Time to remove laryngeal mask airway

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

Incidence of hypotension

Incidence of three consecutive hypotension, which is defined as systolic blood pressure under 80 mmHg, at 2.5 min-intervals

Vasoactive-inotropic score

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)

Full Information

NCT ID

NCT05397886

First Posted

May 9, 2022

Last Updated

September 26, 2022

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05397886

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recovery

Keywords

recovery, remimazolam, flumazenil, propofol, radiofrequency catheter ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remimazolam with flumazenil

Arm Type

Experimental

Arm Description

Arm Title

Propofol total intravenous anesthesia

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Remimazolam Besylate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Flumazenil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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 Outcome Measure Information:

Title

Time to eye opening

Description

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

Time Frame

up to 1 hour

Secondary Outcome Measure Information:

Title

Time to remove laryngeal mask airway

Description

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

Time Frame

up to 1 hour

Title

Incidence of hypotension

Description

Incidence of three consecutive hypotension, which is defined as systolic blood pressure under 80 mmHg, at 2.5 min-intervals

Time Frame

During anesthesia for radiofrequency ablation procedure

Title

Vasoactive-inotropic score

Description

Time Frame

During anesthesia for radiofrequency ablation procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunseok Jeon, MD, PhD

Phone

+82-2-2072-2465

jeonyunseok@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Youn Joung Cho, MD, PhD

Phone

+82-2-2072-2467

mingming7@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yunseok Jeon, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunseok Jeon, MD, PhD

Phone

82-2-2072-2467

jeonyunseok@gmail.com

First Name & Middle Initial & Last Name & Degree

Yunseok Jeon, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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