NCT05035069Unknown4 期
A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
详细描述
This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for TAVR through femoral artery access
- •1h ≤ Expected duration of surgery ≤ 3h
- •Planned for general anesthesia without intubation
- •18 ≤ BMI ≤ 30
- •ASA category Ⅱ～Ⅳ
排除标准
- •Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
- •Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
- •Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
- •Hemoglobin (HB) < 10.0 g / dl (100 g / L)
- •Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
研究组 & 干预措施
Ciprofol
Experimental
干预措施: Ciprofol (Drug)
Propofol
Active Comparator
干预措施: Propofol (Drug)
结局指标
主要结局
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
时间窗: Day 1
次要结局
- Time from the start of drug infusion to the first BIS reduction to 60(Day 1)
- Percentage of subjects received rescue treatment(Day 1)
- Time from the end of drug infusion to the recovery of BIS to 90(Day 1)
- Incidence of hypotension(Day 1)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparison of Propofol Target Controlled Infusion (TCI) and SevofluraneVitreous DetachmentNCT04865991Indonesia University40
尚未招募
不适用
Ciprofol Versus Propofol in Patients Undergoing Painless HysteroscopyPainless HysteroscopyNCT06413862Baoding First Central Hospital188
招募中
不适用
Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort StudyCiprofolPropofolSedationLow Blood PressureNorepinephrineNCT05971121Nanfang Hospital, Southern Medical University456
已完成
4 期
Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).EsketamineLoop Electrosurgical ExcisionPropofolNCT06574945Qian Wu90
尚未招募
不适用
Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic BronchoscopyFiberoptic BronchoscopyNCT06531915Anhui Provincial Hospital190