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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
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
May 9, 2022
Last Updated
September 26, 2022
Sponsor
Seoul National University Hospital
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Arm Title
Propofol total intravenous anesthesia
Arm Type
Active Comparator
Arm 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.
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
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)
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
No
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
Email
jeonyunseok@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Youn Joung Cho, MD, PhD
Phone
+82-2-2072-2467
Email
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
Email
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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