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NCT05486377 Clinical Trial

Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05486377
Other study ID # B-2205-757-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2, 2022
Est. completion date May 19, 2023

Study information
Verified date August 2023
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date May 19, 2023
Est. primary completion date May 19, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 105 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remimazolam besylate
Remimazolam besylate TIVA

Locations
Country Name City State
Korea, Republic of Seoul national university Bundang hospital Seongnam Province (optional)

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vasopressor CIV Vasopressor CIV or not During anesthesia
Primary Hypotension event Hypotension event During and after anesthesia
Primary Vasopressor (total amount) Norepinephrine equivalent dose During anesthesia
Secondary Induction time Induction dose administration~LOC Induction
Secondary Recovery time Reversal agent administration~extubation Recovery
Secondary Adverse event Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.) During and after anesthesia (~24hr)
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