Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

NCT ID: NCT05486377

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2023-05-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Remimazolam Desflurane Cryoablation Arrhythmia General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remimazolam

General anesthesia with remimazolam-remifentanil TIVA.

Group Type EXPERIMENTAL

Remimazolam besylate

Intervention Type DRUG

Remimazolam besylate TIVA

Desflurane

General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remimazolam besylate

Remimazolam besylate TIVA

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

In-Ae Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul national university Bundang hospital

Seongnam, Province (optional), South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38609684 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B-2205-757-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remimazolam Bolus for General Anesthesia
NCT04901871 COMPLETED PHASE3
Anesthetic Techniques in EP Patients
NCT02664922 TERMINATED PHASE4