Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05486377
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Remimazolam; Desflurane; Cryoablation; Arrhythmia; General Anesthesia	Drug: Remimazolam besylate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
• Actual Study Start Date: Aug 2, 2022
• Anticipated Primary Completion Date: Aug 3, 2022
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam General anesthesia with remimazolam-remifentanil TIVA.	Drug: Remimazolam besylate; Remimazolam besylate TIVA
No Intervention: Desflurane General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV)

Outcome Measures

Primary Outcome Measures

1. Vasopressor CIV [During anesthesia]

   Vasopressor CIV or not

2. Hypotension event [During and after anesthesia]

   Hypotension event

3. Vasopressor (total amount) [During anesthesia]

   Norepinephrine equivalent dose

Secondary Outcome Measures

1. Induction time [Induction]

   Induction dose administration~LOC

2. Recovery time [Recovery]

   Reversal agent administration~extubation

3. Adverse event [During and after anesthesia (~24hr)]

   Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 105 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul national university Bundang hospital	Seongnam	Province (optional)	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In-Ae Song, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05486377
• Other Study ID Numbers: B-2205-757-001
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by In-Ae Song, Professor, Seoul National University Bundang Hospital: Remimazolam; Desflurane; Arrhythmia; Cryoablation,heart; Cardiovascular disease
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Aug 3, 2022