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Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05486377
Enrollment
96
Registered
2022-08-03
Start date
2022-08-02
Completion date
2023-05-19
Last updated
2023-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cryoablation, Desflurane, General Anesthesia, Remimazolam

Keywords

Remimazolam, Desflurane, Arrhythmia, Cryoablation,heart, Cardiovascular disease

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).

Interventions

DRUGRemimazolam besylate

Remimazolam besylate TIVA

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 105 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hypotension eventDuring and after anesthesiaHypotension event
Vasopressor (total amount)During anesthesiaNorepinephrine equivalent dose
Vasopressor CIVDuring anesthesiaVasopressor CIV or not

Secondary

MeasureTime frameDescription
Induction timeInductionInduction dose administration\ LOC
Recovery timeRecoveryReversal agent administration\ extubation
Adverse eventDuring and after anesthesia (~24hr)Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026