Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Propofol
- Conditions
- Hemodynamic
- Sponsor
- Taipei Veterans General Hospital, Taiwan
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Hemodynamic stability--Vasopressor dosage
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief 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.
Investigators
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
Arms & Interventions
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.
Intervention: Propofol
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.
Intervention: With 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.
Intervention: Remimazolam
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.
Intervention: With 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).
Intervention: Propofol
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).
Intervention: Maintain 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).
Intervention: Remimazolam
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).
Intervention: Maintain spontaneous ventilation without intubation
Outcomes
Primary Outcomes
Hemodynamic stability--Vasopressor dosage
Time Frame: Introperative
Total dosage of vasopressor used during the procedure
Secondary Outcomes
- Respiratory depression require intubation(Introperative)
- TIVA failure rate(Introperative)
- LOC time(Introperative)
- Emergence time(Introperative)
- Sanctification of cardiologist(Perioperative)
- QoR-15(Preoperative to post-operative day 1)
- Mini-Cog(Preoperative to post-operative day 1)
- Length of hospital stay(Upto 1 month)
- Adverse outcome(Upto 1 month)
- Length of CU stay(Upto 1 month)