Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Processed electroencephalography (pEEG) Guided General Anesthesia, Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring).
- Who it may be relevant to
- Registry conditions: Postoperative Acute Kidney Injury. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Reduced Intraoperative Norepinephrine Requirements Via Processed Electroencephalography-Guided General Anesthesia on Patient Outcomes After Major Abdominal Surgeries
Overview
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).
Detailed description
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.
One important factor contributing to IOH and vasopressor use is excessively deep 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 vasopressor .
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Incidence of postoperative acute kidney injury (AKI) based on the KDIGO criteria. [Time frame: Assessed at the third postoperative day.]
Secondary outcome measures (2)
- 1.Total dose of norepinephrine administrated [Time frame: 48 hour]
- 2.The volume of intraoperative fluid therapy. [Time frame: 48 hour]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Pregnancy.
- Patient refusal to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Assiut University Hospitals — Asyut
Identifiers
NCT: NCT06753409 · EEG-Guided General Anesthesia