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Completed

NCT Number: NCT05486377

Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

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).

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Key information

Conditions

Remimazolam Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Cryoablation Desflurane General Anesthesia Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul national university Bundang hospital

Seongnam, Province (optional), 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam besylate

Drug

Remimazolam besylate TIVA

Primary outcomes

  1. Vasopressor CIV

    Time frame: During anesthesia

    Vasopressor CIV or not

  2. Hypotension event

    Time frame: During and after anesthesia

    Hypotension event

  3. Vasopressor (total amount)

    Time frame: During anesthesia

    Norepinephrine equivalent dose

Secondary outcomes

  1. Induction time

    Time frame: Induction

    Induction dose administration~LOC

  2. Recovery time

    Time frame: Recovery

    Reversal agent administration~extubation

  3. Adverse event

    Time frame: During and after anesthesia (~24hr)

    Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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