EEG-guided General Anesthesia vs. Routine Care and Cumulative Dose of Norepinephrine in Patients Having Vascular Surgery: a Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 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
- 是
入选标准
- •We will include consenting patients ≥45 years scheduled for elective vascular surgery under general anesthesia if:
- •surgery is expected to last at least 60 min AND
- •the estimated blood loss during surgery is less than 1000 mL AND
- •intraarterial blood pressure monitoring (arterial catheter) is planned during surgery
- •We will not include patients with previous transplantation of kidney, liver, heart, or lung and those who are septic (according to current Sepsis-3 definition). And we will not include patients with American Society of Anesthesiologists' physical status V and VI, or pregnancy.
- •We will exclude patients after randomization if they were treated with vasopressors others than norepinephrine during surgery.
- •Written informed consent will be obtained from all patients prior to study inclusion.
排除标准
- 未提供
研究组 & 干预措施
EEG-guided general anesthesia
EEG-guided general anesthesia group (i.e., intervention group): For pEEG monitoring we will use the SEDLine monitor (Masimo, Irvine, CA) which provides the patient state index (PSi; a processed EEG parameter with values from 1 to 100), density spectral array (DSA; a display that represents the frequencies and amplitudes of brain waves through time), spectral edge frequency (SEF), and the raw EEG signal.
干预措施: EEG-guided general anesthesia (Device)
Routine care
Routine care group (i.e., control group): Adjustment of depth of general anesthesia will be at the discretion of the treating anesthesiologist.
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
- Incidence and severity of intraoperative hypotension(Outcome meassure will be assessed at the end of surgery)
- 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)
研究者
Kristen Thomsen
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf