RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation
NCT06700681 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-11-22
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
- 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.
Sponsors & Collaborators
-
Taipei Veterans General Hospital, Taiwan
lead OTHER_GOV
Principal Investigators
-
Li Yi-Shiuan, Bachelor's · Taipei Veterans General Hospital, Taiwan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-20
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Taiwan
Study Locations
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