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NCT Number: NCT06753409

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospitals

Asyut, Egypt

Location status: Recruiting

Location contact

Vice president of graduate studies of Assiut University

CONTACT

[email protected]

+2088 22080

Walaa H Mohamed, Assistant Lecturer

PRINCIPAL_INVESTIGATOR

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Processed electroencephalography (pEEG) Guided General Anesthesia

Device

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)

Device

Depth of anesthesia will be managed based on clinical judgment, informed by clinical perception and vital signs.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. 1.Total dose of norepinephrine administrated

    Time frame: 48 hour

    The total cumulative dose of norepinephrine administered intraoperatively and postoperatively will be recorded in micrograms.

  2. 2.The volume of intraoperative fluid therapy.

    Time frame: 48 hour

    The volume of crystalloids, colloids, and blood products administered intraoperatively will be recorded in (milliliters).

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa S Abbas, Professor

CONTACT

[email protected]

+201003060187

Walaa H Mohamed, Assistant Lecturer

CONTACT

[email protected]

+201061403338

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Reduced Intraoperative Norepinephrine Requirements Via Processed Electroencephalography-Guided General Anesthesia on Patient Outcomes After Major Abdominal Surgeries

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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