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临床试验/NCT05940649
NCT05940649已完成不适用

Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial

Kristen Thomsen1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2023年7月3日最近更新:
适应症
干预措施

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

Experimental

干预措施: Continuous norepinephrine administration (Procedure)

Bolus norepinephrine administration

No Intervention

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kristen Thomsen

Dr.

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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