Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

August 7, 2023 updated by: In-Ae Song, Seoul National University Bundang Hospital

Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Province (optional)
      • Seongnam, Province (optional), Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam
General anesthesia with remimazolam-remifentanil TIVA.
Drug: Remimazolam besylate
Remimazolam besylate TIVA
No Intervention: Desflurane
General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasopressor CIV
Time Frame: During anesthesia
Vasopressor CIV or not
During anesthesia
Hypotension event
Time Frame: During and after anesthesia
Hypotension event
During and after anesthesia
Vasopressor (total amount)
Time Frame: During anesthesia
Norepinephrine equivalent dose
During anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction time
Time Frame: Induction
Induction dose administration~LOC
Induction
Recovery time
Time Frame: Recovery
Reversal agent administration~extubation
Recovery
Adverse event
Time Frame: During and after anesthesia (~24hr)
Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)
During and after anesthesia (~24hr)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

May 19, 2023

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2205-757-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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