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
1 other identifier
interventional
96
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2022
CompletedStudy Start
First participant enrolled
August 2, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2023
CompletedAugust 9, 2023
August 1, 2023
10 months
August 1, 2022
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Vasopressor CIV
Vasopressor CIV or not
During anesthesia
Hypotension event
Hypotension event
During and after anesthesia
Vasopressor (total amount)
Norepinephrine equivalent dose
During anesthesia
Secondary Outcomes (3)
Induction time
Induction
Recovery time
Recovery
Adverse event
During and after anesthesia (~24hr)
Study Arms (2)
Remimazolam
EXPERIMENTALGeneral anesthesia with remimazolam-remifentanil TIVA.
Desflurane
NO INTERVENTIONGeneral anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV)
Interventions
Eligibility Criteria
You may qualify if:
- =or \> 20 years
- Admission for General anesthesia for RFCA or cryoablation procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university Bundang hospital
Seongnam, Province (optional), 13620, South Korea
Related Publications (1)
Yim S, Choi CI, Park I, Koo BW, Oh AY, Song IA. Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial. Can J Anaesth. 2024 Aug;71(8):1067-1077. doi: 10.1007/s12630-024-02735-z. Epub 2024 Apr 12.
PMID: 38609684DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2022
First Posted
August 3, 2022
Study Start
August 2, 2022
Primary Completion
May 19, 2023
Study Completion
May 19, 2023
Last Updated
August 9, 2023
Record last verified: 2023-08