Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hemodynamic stability--Vasopressor dosage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Propofol (Drug)
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.
干预措施: With intubation and controlled ventilation to maintain airway (Device)
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.
干预措施: Remimazolam (Drug)
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.
干预措施: With intubation and controlled ventilation to maintain airway (Device)
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).
干预措施: Propofol (Drug)
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).
干预措施: Maintain spontaneous ventilation without intubation (Device)
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).
干预措施: Remimazolam (Drug)
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).
干预措施: Maintain spontaneous ventilation without intubation (Device)
结局指标
主要结局
Hemodynamic stability--Vasopressor dosage
时间窗: Introperative
Total dosage of vasopressor used during the procedure
次要结局
- 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)