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Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

Primary Purpose

Remimazolam, Desflurane, Cryoablation

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam besylate
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Remimazolam focused on measuring Remimazolam, Desflurane, Arrhythmia, Cryoablation,heart, Cardiovascular disease

Eligibility Criteria

20 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • =or > 20 years
  • Admission for General anesthesia for RFCA or cryoablation procedure

Exclusion Criteria:

  • No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
  • Acute alcoholic intoxication state
  • Coma or shock state due to other condition than heart problem.
  • Acute narrow-angle glaucoma

Sites / Locations

  • Seoul national university Bundang hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remimazolam

Desflurane

Arm Description

General anesthesia with remimazolam-remifentanil TIVA.

General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV)

Outcomes

Primary Outcome Measures

Vasopressor CIV
Vasopressor CIV or not
Hypotension event
Hypotension event
Vasopressor (total amount)
Norepinephrine equivalent dose

Secondary Outcome Measures

Induction time
Induction dose administration~LOC
Recovery time
Reversal agent administration~extubation
Adverse event
Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)

Full Information

First Posted
August 1, 2022
Last Updated
August 7, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05486377
Brief Title
Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia
Official Title
Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
May 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remimazolam, Desflurane, Cryoablation, Arrhythmia, General Anesthesia
Keywords
Remimazolam, Desflurane, Arrhythmia, Cryoablation,heart, Cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
General anesthesia with remimazolam-remifentanil TIVA.
Arm Title
Desflurane
Arm Type
No Intervention
Arm Description
General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV)
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Intervention Description
Remimazolam besylate TIVA
Primary Outcome Measure Information:
Title
Vasopressor CIV
Description
Vasopressor CIV or not
Time Frame
During anesthesia
Title
Hypotension event
Description
Hypotension event
Time Frame
During and after anesthesia
Title
Vasopressor (total amount)
Description
Norepinephrine equivalent dose
Time Frame
During anesthesia
Secondary Outcome Measure Information:
Title
Induction time
Description
Induction dose administration~LOC
Time Frame
Induction
Title
Recovery time
Description
Reversal agent administration~extubation
Time Frame
Recovery
Title
Adverse event
Description
Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)
Time Frame
During and after anesthesia (~24hr)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: =or > 20 years Admission for General anesthesia for RFCA or cryoablation procedure Exclusion Criteria: No severe adverse effect history or hypersensitivity of benzodiazepines or its additives Acute alcoholic intoxication state Coma or shock state due to other condition than heart problem. Acute narrow-angle glaucoma
Facility Information:
Facility Name
Seoul national university Bundang hospital
City
Seongnam
State/Province
Province (optional)
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

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Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

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