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Recruiting Not applicable

Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery

NCT06753409 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-02-01
Last updated
2025-02-04

Condition(s) studied

Postoperative Acute Kidney Injury

Investigational drug(s) / intervention(s)

Processed electroencephalography (pEEG) Guided General AnesthesiaNon-pEEG-Guided General Anesthesia (with blinded pEEG monitoring)

Processed electroencephalography (pEEG) Guided General Anesthesia: Processed 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): Depth of anesthesia will be managed based on clinical judgment, informed by clinical perception and vital signs.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients scheduled for major abdominal surgery lasting more than 2 hours under general anesthesia. 2. American Society of Anesthesiologists Physical Status (ASA) score I-III. 3. Age range of 18-70 years. 4. Both male and female patients. Exclusion Criteria: 1. Emergency surgeries. 2. Uncontrolled hypertension (systolic blood pressure \>150 mm Hg) despite medication. 3. Recent acute cardiovascular events, including heart failure or acute coronary syndrome. 4. Chronic kidney disease with a glomerular filtration rate \<30 ml/min/1.73 m² or requiring renal replacement therapy. 5. Severe hepatic failure (ASAT/ALAT \>2N, elevated bilirubin, or PT \<50%). 6. Preoperative sepsis or septic shock. 7. Pregnancy. 8. Patient refusal to participate in the study.

Primary outcome measure(s)

  • Incidence of postoperative acute kidney injury (AKI) based on the KDIGO criteria. — 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.

Trial sites (1)

FacilityCityRegionStatus
Assiut University Hospitals Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06753409 on ClinicalTrials.gov ↗ ← All trials in Egypt