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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA with Propofol and intubation | Placebo Comparator | Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation. |
|
| TIVA with Remimazolam and intubation | Experimental | Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation. |
|
| TIVA with Propofol and non-Intubated | Experimental | 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). |
|
| TIVA with Remimazolam and non-Intubated | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | TIVA induction and maintain with Propofol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic stability--Vasopressor dosage | Total dosage of vasopressor used during the procedure | Introperative |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory depression require intubation | The incidence of patients in non-intubated groups receive intubation | Introperative |
| TIVA failure rate | The incidence of TIVA shift to inhalation anesthetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Yi-Shiuan, Bachelor's | Taipei Veterans General Hospital, Taiwan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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| Remimazolam | Drug | TIVA induction and maintain with Remimazolam. |
|
| With intubation and controlled ventilation to maintain airway | Device | Patient receives intubation and controlled ventilation to maintain airway. |
|
| Maintain spontaneous ventilation without intubation | Device | Patient maintains spontaneous ventilation without intubation. |
|
| Introperative |
| LOC time | Time from start induction to loss of conscious | Introperative |
| Emergence time | Time from stop intravenous anesthetics infusion to eye opening | Introperative |
| Sanctification of cardiologist | The sanctification score of the cardiologist | Perioperative |
| QoR-15 | The result of QoR-15 score | Preoperative to post-operative day 1 |
| Mini-Cog | The result of Mini-Cog score | Preoperative to post-operative day 1 |
| Length of hospital stay | Length of hospital stay | Upto 1 month |
| Adverse outcome | Any adverse outcome | Upto 1 month |
| Length of CU stay | Length of CU stay | Upto 1 month |
| ID | Term |
|---|---|
| D015742 | Propofol |
| C522201 | remimazolam |
| D007440 | Intubation |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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