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).
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.
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.
Parallel
Processed electroencephalography (pEEG) Guided General Anesthesia
DeviceProcessed electroencephalography (pEEG) can guide the optimization of anesthesia depth, potentially preventing overly deep anesthesia and, in turn, reducing the incidence of IOH and the need for vasopressors . Depth of anesthesia will be managed based on pEEG monitoring using Entropy with a target range of 40-60.
Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring)
DeviceDepth of anesthesia will be managed based on clinical judgment, informed by clinical perception and vital signs.
Incidence of postoperative acute kidney injury (AKI) based on the KDIGO criteria.
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.
1.Total dose of norepinephrine administrated
The total cumulative dose of norepinephrine administered intraoperatively and postoperatively will be recorded in micrograms.
2.The volume of intraoperative fluid therapy.
The volume of crystalloids, colloids, and blood products administered intraoperatively will be recorded in (milliliters).
Click on the lead sponsor to view all of their trials.
