Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Blood pressure stability
研究概览
简要总结
This is a randomized trial investigating whether continuous norepinephrine administration via an infusion pump - compared to manual bolus administration - increases blood pressure stability within the first 15 minutes of anesthetic induction in non-cardiac surgery patients.
The secondary endpoints area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min], cumulative duration of a MAP <65, <60, <50, and <40 mmHg [min], area above a MAP of 100, 110, 120, and 140 mmHg [mmHg min], cumulative duration of a MAP >100, >110, >120, and >140 mmHg [min] and cumulative dose of norepinephrine indexed to body weight [μg/kg] within the first 15 minutes of anesthetic induction will be assessed.
详细描述
not provided
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 45 years
- •American Society of Anesthesiologists physical status II-IV
- •scheduled for elective major non-cardiac surgery under general anesthesia
- •continuous intraarterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the trial
- •sinus rhythm
排除标准
- •Clinical indication to use a continuous norepinephrine infusion via an infusion pump during anesthetic induction
- •Need for femoral artery catheterization
- •History of intracranial bleedings or aneurysms
- •Patients who are incapable of giving consent
- •Pregnancy
研究组 & 干预措施
Manual bolus norepinephrine administration
manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists
干预措施: Manual bolus norepinephrine administration (Other)
Continuous norepinephrine administration
continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists
干预措施: Continuous norepinephrine infusion via an infusion pump (Other)
结局指标
主要结局
Blood pressure stability
时间窗: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Generalized average real variability (gARV) of mean arterial pressure (MAP) within the first 15 minutes of anesthetic induction \[mmHg/min\]; the gARV is the sum of absolute values of the differences between neighboring measurements for all measurements divided by the total measurement duration in \[mmHg/min\].
次要结局
- Area under MAP(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
- Cumulative duration of a MAP below(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
- Cumulative dose of norepinephrine(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
- Area above MAP(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
- Cumulative duration of a MAP above(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)