Remimazolam for Procedural Sedation in Cardiac Patients Undergoing Transesophageal Echocardiogram Procedures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Incidence of intra-procedural hypotension
研究概览
简要总结
This is a prospective randomized study. The purpose of this study is to compare the use of remimazolam vs propofol (standard practice) for transesophageal echocardiogram (TEE). Remimazolam was approved by the Pharmacy and Therapeutics committee as a formulary addition to be utilized by anesthesiology for procedural sedation in October 2021. Cardiac patients undergoing TEE procedures at Mount Sinai Morningside Medical Center will be evaluated - 100 patients with be randomized to either receive remimazolam or standard anesthesia. Research participation will include the following activities: prospective access to the Medical Record through Epic only (no other database). Consent to collect patient data for this study will be obtained from subjects by the anesthesiologist at the same time as obtaining consent for the medical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •all cardiac patients undergoing elective TEE examination
排除标准
- •Patients with hypersensitivity to dextrans
- •Emergent procedures
- •Patient with allergy to any of the anesthetic agents
- •Patient refusal
研究组 & 干预措施
Propofol group
Control group receiving standard therapy. 50-100mg/kg/min titrated at the discretion of the anesthesiology team
干预措施: Propofol (Drug)
Remimazolam group
Study group receiving study drug 0.1-0.2mg/kg/min titrated to effect
干预措施: Remimazolam (Drug)
结局指标
主要结局
Incidence of intra-procedural hypotension
时间窗: during procedure
Incidence of intra-procedural hypotension defined as MAP \<65 mmHg or \>20% decrease from baseline.
次要结局
- Number of Procedural Success(Immediately after procedure)
- Time to recovery(Time in recovery area, average of 2-4 hours)
- Incidence of treatment-related adverse events(up to 24 hours)
研究者
Himani Bhatt-Verma
Associate Professor
Icahn School of Medicine at Mount Sinai