RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation
NCT ID: NCT06700681
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
200 participants
INTERVENTIONAL
2024-09-20
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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TIVA with Propofol and intubation
Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation.
Propofol
TIVA induction and maintain with Propofol.
With intubation and controlled ventilation to maintain airway
Patient receives intubation and controlled ventilation to maintain airway.
TIVA with Remimazolam and intubation
Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation.
Remimazolam
TIVA induction and maintain with Remimazolam.
With intubation and controlled ventilation to maintain airway
Patient receives intubation and controlled ventilation to maintain airway.
TIVA with Propofol and non-Intubated
Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated).
Propofol
TIVA induction and maintain with Propofol.
Maintain spontaneous ventilation without intubation
Patient maintains spontaneous ventilation without intubation.
TIVA with Remimazolam and non-Intubated
Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated).
Remimazolam
TIVA induction and maintain with Remimazolam.
Maintain spontaneous ventilation without intubation
Patient maintains spontaneous ventilation without intubation.
Interventions
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Propofol
TIVA induction and maintain with Propofol.
Remimazolam
TIVA induction and maintain with Remimazolam.
With intubation and controlled ventilation to maintain airway
Patient receives intubation and controlled ventilation to maintain airway.
Maintain spontaneous ventilation without intubation
Patient maintains spontaneous ventilation without intubation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient refusal or cannot finish Mini-Cog or QoR-15 preoperatively
* Canceled by cardiologist
* Allergy history to the anesthetics used in this study
* History of abnormal lung function or required oxygen therapy preoperative
20 Years
80 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Li Yi-Shiuan, Bachelor's
Role: STUDY_DIRECTOR
Taipei Veterans General Hospital, Taiwan
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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2024-06-005B
Identifier Type: -
Identifier Source: org_study_id
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