Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Hypotension during anesthetic induction
研究概览
简要总结
Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. About one third of intraoperative hypotension occurs during anesthetic induction - i.e., between the start of anesthetic induction and surgical incision. Hypotension during anesthetic induction is associated with postoperative acute kidney injury.
Unmodifiable risk factors for hypotension during anesthetic induction include age, male sex, and a high American Society of Anesthesiologists physical status class. However, hypotension during anesthetic induction is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation.
In most German hospitals, norepinephrine is the first-line vasopressor to treat hypotension during anesthetic induction. Norepinephrine is usually given as repeated manual boluses of 5, 10, or 20 μg. The continuous administration of norepinephrine via a perfusion pump is usually started only later. It remains unknown whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction.
We thus propose to investigate whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction in non-cardiac surgery patients.
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, Outcomes Assessor)
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
- •non-cardiac surgery
- •>45 years of age
- •American Society of Anesthesiologists physical status classification II, III, and IV.
排除标准
- •Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter
- •Emergency surgery
- •Transplant surgery
- •History of organ transplant
- •Pregnancy
- •Heart rhythms other than sinus rhythm
- •Impossible Finger-cuff blood pressure monitoring
- •Rapid sequence induction
研究组 & 干预措施
Continuous norepinephrine administration
干预措施: Continuous norepinephrine administration (Procedure)
Bolus norepinephrine administration
结局指标
主要结局
Hypotension during anesthetic induction
时间窗: First 15 minutes of anesthetic induction
Area under a MAP of 65 mmHg \[mmHg x min\]
次要结局
- Hypotension during anesthetic induction(First 15 minutes of anesthetic induction)
- Hypertension during anesthetic induction(First 15 minutes of anesthetic induction)
研究者
Kristen Thomsen
Dr.
Universitätsklinikum Hamburg-Eppendorf
