NCT06700681

RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation

Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary: The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. The main questions it aims to answer are: * Is Remimazolam as efficacy as propofol in cardiac electrophysiology studies and ablation? * Is Remimazolam lower hypotension episodes or lower vasopressor dosages compare with propofol in cardiac electrophysiology studies and ablation? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Researchers will compare Remimazolam to Propofol to see if Remimazolam is more feasible in cardiac electrophysiology studies and ablation. Participants will receive either Remimazolam or Propofol sedation during study period.

Conditions

• Hemodynamic
• Remimazolam
• Propofol
• Cardiac Electrophysiology

Interventions

Type	Name	Description
DRUG	Propofol	TIVA induction and maintain with Propofol.
DRUG	Remimazolam	TIVA induction and maintain with Remimazolam.
DEVICE	With intubation and controlled ventilation to maintain airway	Patient receives intubation and controlled ventilation to maintain airway.
DEVICE	Maintain spontaneous ventilation without intubation	Patient maintains spontaneous ventilation without intubation.

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-11-22
• Last updated: 2024-11-22

Locations

1 site across 1 country: Taiwan