Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

Phase 4

Completed

• Conditions: General Anesthesia; Remimazolam; Desflurane; Cryoablation; Arrhythmia
• Interventions: Drug: Remimazolam besylate

• Registration Number: NCT05486377
• Lead Sponsor: Seoul National University Bundang Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-01
• Study Start: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Primary Completion: 2023-05-19
• Study Completion: 2023-05-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	Remimazolam besylate	General anesthesia with remimazolam-remifentanil TIVA.

Primary Outcome Measures

Name	Time	Method
Hypotension event	During and after anesthesia	Hypotension event
Vasopressor (total amount)	During anesthesia	Norepinephrine equivalent dose
Vasopressor CIV	During anesthesia	Vasopressor CIV or not

Secondary Outcome Measures

Name	Time	Method
Induction time	Induction	Induction dose administration\~LOC
Recovery time	Recovery	Reversal agent administration\~extubation
Adverse event	During and after anesthesia (~24hr)	Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)

Trial Locations

Locations (1)

Seoul national university Bundang hospital; 🇰🇷 Seongnam, Province (optional), Korea, Republic of