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临床试验/NCT05293288
NCT05293288已完成不适用

EEG-guided General Anesthesia vs. Routine Care and Cumulative Dose of Norepinephrine in Patients Having Vascular Surgery: a Pilot Randomized Trial

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Cumulative norepinephrine dose

研究概览

简要总结

Intraoperative hypotension is common in patients having non-cardiac surgery under general anesthesia and is associated with major postoperative complications including myocardial injury, AKI, and death.

Intraoperative hypotension is also common in patients having vascular surgery. To treat intraoperative hypotension, vasopressors - such as norepinephrine - and fluids are used. However, high-dose vasopressor and excessive fluid therapy are also associated with postoperative complications.

The depth of general anesthesia may be a modifiable cause of intraoperative hypotension. Deep levels of general anesthesia may cause cardiovascular depression with intraoperative hypotension and higher vasopressor requirements. Optimal depth of general anesthesia is defined as a state in which the patient is at low risk of recall of intraoperative events while maintaining blood pressure stability with minimal intervention.

Depth of anesthesia can be confirmed using clinical signs, the concentration of inhaled or intravenous anesthetics, or neuromonitoring such as processed electroencephalography (pEEG). pEEG presents an opportunity to monitor changes in human brain electrical activity and to help estimating the patients' level of (un)consciousness and the optimal depth of anesthesia. EEG-guided general anesthesia may thus decrease norepinephrine doses needed to treat intraoperative hypotension in patients having surgery.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cumulative norepinephrine dose

时间窗: Outcome meassure will be assessed at the end of surgery

Time-weighted cumulative norepinephrine dose normalized to the patient's actual body weight: cumulative norepinephrine dose \[µg\] / body weight \[kg\] / length of surgery \[min\]; unit: µg/kg/min

次要结局

  • Hospital mortality(Through study completion, an average of 1 year)
  • ICU length of stay(Through study completion, an average of 1 year)
  • Hospital length of stay(Through study completion, an average of 1 year)
  • Incidence and severity of intraoperative hypotension(Outcome meassure will be assessed at the end of surgery)

研究者

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

Kristen Thomsen

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (2)

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