RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol, Remimazolam, With intubation and controlled ventilation to maintain airway, Maintain spontaneous ventilation without intubation.
- Who it may be relevant to
- Registry conditions: Hemodynamic, Remimazolam, Propofol, Cardiac Electrophysiology. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial
Overview
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.
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.
Primary outcome measures
- Hemodynamic stability--Vasopressor dosage [Time frame: Introperative]
Secondary outcome measures (10)
- Respiratory depression require intubation [Time frame: Introperative]
- TIVA failure rate [Time frame: Introperative]
- LOC time [Time frame: Introperative]
- Emergence time [Time frame: Introperative]
- Sanctification of cardiologist [Time frame: Perioperative]
- QoR-15 [Time frame: Preoperative to post-operative day 1]
- Mini-Cog [Time frame: Preoperative to post-operative day 1]
- Length of hospital stay [Time frame: Upto 1 month]
- Adverse outcome [Time frame: Upto 1 month]
- Length of CU stay [Time frame: Upto 1 month]
Eligibility criteria
Inclusion criteria
- Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).
Exclusion criteria
- With existing vasopressor or shock status
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT06700681 · 2024-06-005B