Impact of Reduced Intraoperative Norepinephrine Requirements Via Processed Electroencephalography-Guided General Anesthesia on Patient Outcomes After Major Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Incidence of postoperative acute kidney injury (AKI) based on the KDIGO criteria.
研究概览
简要总结
This study aims to evaluate whether the reduction in the amount of intraoperative norepinephrine required to prevent hypotension, facilitated by processed electroencephalography (pEEG) -guided general anesthesia, will lead to a decrease in postoperative complications, particularly acute kidney injury (AKI).
详细描述
In major abdominal surgery, intraoperative hypotension (IOH) remains a prevalent concern, contributing significantly to postoperative complications. These complications include acute kidney injury (AKI), myocardial injury, and even mortality. While IOH is multifactorial, its occurrence is frequently associated with the need for vasopressor support, particularly norepinephrine, which is widely used to manage and prevent IOH. However, it is important to note that vasopressors, including norepinephrine, are themselves implicated in promoting AKI .
The lack of consensus on a universal definition for IOH adds complexity to this issue. Currently, it remains unclear whether IOH should be defined based on absolute blood pressure thresholds or as a relative decrease from baseline. IOH is commonly defined as a systolic blood pressure of <90 mm Hg or a mean arterial pressure (MAP) of <65 mm Hg.
Ephedrine is often the first-line vasopressor administered to treat IOH, with norepinephrine as a second-line option. The hemodynamic effects of these two agents differ: norepinephrine increases cardiac preload without significantly increasing afterload, thereby raising cardiac output. Ephedrine, however, increases cardiac output but with a greater increase in afterload, often leading to tachycardia, which can be detrimental to patients. The variable effectiveness of ephedrine and its associated side effects have led clinicians to consider norepinephrine as a more appropriate option for managing IOH, potentially with fewer cardiovascular side effects.
Additionally, crystalloid fluid overload during abdominal surgery has been linked to poor postoperative outcomes, including anastomotic instability. Liberal fluid regimes may disrupt the physiological healing processes at surgical sites, suggesting that fluid management strategies aimed at minimizing overload could improve patient outcomes.
Recent studies propose that early norepinephrine administration to maintain MAP, even before the onset of hypotension, may help reduce the need for large fluid volumes.
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
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for major abdominal surgery lasting more than 2 hours under general anesthesia.
- •American Society of Anesthesiologists Physical Status (ASA) score I-III.
- •Age range of 18-70 years.
- •Both male and female patients.
排除标准
- •Emergency surgeries.
- •Uncontrolled hypertension (systolic blood pressure >150 mm Hg) despite medication.
- •Recent acute cardiovascular events, including heart failure or acute coronary syndrome.
- •Chronic kidney disease with a glomerular filtration rate <30 ml/min/1.73 m² or requiring renal replacement therapy.
- •Severe hepatic failure (ASAT/ALAT >2N, elevated bilirubin, or PT <50%).
- •Preoperative sepsis or septic shock.
- •Patient refusal to participate in the study.
研究组 & 干预措施
pEEG-Guided General Anesthesia Group
Depth of anesthesia will be managed based on pEEG monitoring using Entropy with a target range of 40-60.
干预措施: Processed electroencephalography (pEEG) Guided General Anesthesia (Device)
Non-pEEG-Guided Anesthesia (Standard Care Group) with blinded pEEG monitoring
Depth of anesthesia will be managed based on clinical judgment, informed by clinical perception and vital signs.
干预措施: Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring) (Device)
结局指标
主要结局
Incidence of postoperative acute kidney injury (AKI) based on the KDIGO criteria.
时间窗: Assessed at the third postoperative day.
Diagnosis and severity of PO-AKI will be assessed by serum-creatinine and/or urine output according to the KDIGO criteria . The latest serum creatinine before surgery will be defined as baseline value. Serum creatinine will be measured at least once a day for the first 3 days. Patients with serum creatinine increases of ≥0.3 mg/dl within 48 h or 1.5-1.9 times increases within 72 h after surgery will be diagnosed KDIGO stage 1, patients with serum creatinine increases of 2-2.9 times within 72 h will be diagnosed KDIGO stage 2, and patients with serum creatinine increases of ≥3 times or ≥4 mg/dl or with the need of renal replacement therapy (RRT) will be diagnosed KDIGO stage 3. Further, patients with a urine out- put \<0.5 ml/kg/h for ≥6 h will be diagnosed KDIGO stage 1, urine output \<0.5 ml/kg/h for ≥12 h KDIGO stage 2, and \<0.3 ml/kg/h for ≥24 h or anuria for ≥12 h KDIGO stage 3. Once the urine catheter removed, the urine output criterion will no longer be considered.
次要结局
- 1.Total dose of norepinephrine administrated(48 hour)
- 2.The volume of intraoperative fluid therapy.(48 hour)
研究者
walaa hamdy mohamed hemaid
Assistant Lecturer
Assiut University
