NCT05415436已完成3 期
Analyzing the Relationship Between Rate of Induction and Perioperative Hypotension Using Propofol
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patients Administered Propofol at a Slower Rate of Infusion Will Have Lower Incidence of Post Induction Hypotension Than Patients Administered Propofol at FDA Approved Rate.
研究概览
简要总结
The objective of this study is to evaluate the hemodynamic changes related to Propofol administration rate. We hypothesize that slow administration of IV propofol will have less hemodynamic disturbances and will require less amount of vasoactive medication for BP correction when compared to standard FDA approved administration rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any patient from 18 till 80 years of age
- •patient undergoing non-cardiac elective surgery
- •duration of the surgery longer than one hour
- •native/fluent English speaker
- •patients whose staff anesthesiologist planned to use Propofol as a primary anesthetic for induction
排除标准
- •any patient admitted for non-elective surgery
- •any patient undergoing cardiac surgery
- •any patient under 18 years of age
- •any patient older than 80 years of age
- •any patient with history of severe heart disease (CHF with significant limitations of activity due to sever symptoms, prior heart surgery, atrial fibrillation, etc.)
- •any patient with pre-operative hemodynamic instability (e.g. sepsis, chronic kidney disease, liver cirrhosis) who requires constant or intermittent administration of vasoactive or inotropic medication to support vital signs (BP)
- •any patient on vasoactive or inotrop medications in early pre-operative period (within 24 hours prior to the surgery)
- •any patient who does not speak English or not fluently
- •any patient with cognitive impairment or mentally incapacitation
- •any pregnant or breastfeeding females
- •any patient whose staff anesthesiologist planned to use a primary anesthetic other than Propofol
结局指标
主要结局
Patients Administered Propofol at a Slower Rate of Infusion Will Have Lower Incidence of Post Induction Hypotension Than Patients Administered Propofol at FDA Approved Rate.
时间窗: induction to 1 hour post induction
We will collect the patient's blood pressure intra-operatively every 5 minutes starting on induction up to one hour after induction and compare.
次要结局
- Patients Administered Propofol at a Slower Rate Will Have Less Complications During the Early Post-op Period Than Patients Administered Propofol at FDA Approved Rate.(immediate post-op to 30 days post operatively)
研究者
研究点 (2)
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