Postoperative Acute Kidney InjuryNCT06753409
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
A study testing Processed electroencephalography (pEEG) Guided General Anesthesia and Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring) in people with Postoperative Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Acute Kidney Injury
- What is being tested?
- Processed electroencephalography (pEEG) Guided General Anesthesia and Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals
Asyut
Vice president of graduate studies of Assiut University, +2088 22080, vp_grad@aun.edu.eg
Walaa H Mohamed, Assistant Lecturer
About this study
Official title: Impact of Reduced Intraoperative Norepinephrine Requirements Via Processed Electroencephalography-Guided General Anesthesia on Patient Outcomes After Major Abdominal Surgeries
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).
Read the 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 .
- Conditions
- Postoperative Acute Kidney Injury
- Being tested
- Processed electroencephalography (pEEG) Guided General Anesthesia, Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring)
- Keywords
- Hypotension, Abdominal surgery, Norepinephrine, Acute kidney injury
- Medical subject headings
- Hypotension, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed electroencephalography (pEEG) Guided General AnesthesiaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| pEEG-Guided General Anesthesia Group | Active comparator | Depth of anesthesia will be managed based on pEEG monitoring using Entropy with a target range of 40-60. Receives: Device: Processed electroencephalography (pEEG) Guided General Anesthesia |
| Non-pEEG-Guided Anesthesia (Standard Care Group) with blinded pEEG monitoring | Placebo comparator | Depth of anesthesia will be managed based on clinical judgment, informed by clinical perception and vital signs. Receives: Device: Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the third postoperative day.
Secondary outcomes (2)
1.Total dose of norepinephrine administrated
The total cumulative dose of norepinephrine administered intraoperatively and postoperatively will be recorded in micrograms.
Measured: 48 hour
2.The volume of intraoperative fluid therapy.
The volume of crystalloids, colloids, and blood products administered intraoperatively will be recorded in (milliliters).
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa hamdy mohamed hemaid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753409
- Sponsor's protocol ID
- EEG-Guided General Anesthesia
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduced Intraoperative Norepinephrine Requirements Via Processed Electroencephalography-Guided General Anesthesia on Patient Outcomes After Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06753409
- Acronym / sponsor ID
- EEG-Guided General Anesthesia
- Conditions
- Postoperative Acute Kidney Injury
- Keywords
- Hypotension, Abdominal surgery, Norepinephrine, Acute kidney injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pEEG-Guided General Anesthesia Group | Active comparator | Device: Processed electroencephalography (pEEG) Guided General AnesthesiaDepth of anesthesia will be managed based on pEEG monitoring using Entropy with a target range of 40-60. |
| Non-pEEG-Guided Anesthesia (Standard Care Group) with blinded pEEG monitoring | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Processed electroencephalography (pEEG) Guided General AnesthesiaProcessed 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 | pEEG-Guided General Anesthesia Group |
| 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. | Device | Non-pEEG-Guided Anesthesia (Standard Care Group) with blinded pEEG monitoring |
Primary outcome
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.
2 secondary outcomes
1.Total dose of norepinephrine administrated
Time frame: 48 hour
2.The volume of intraoperative fluid therapy.
Time frame: 48 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed electroencephalography (pEEG) Guided General Anesthesia and Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring) in people with Postoperative Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walaa H Mohamed, Assistant Lecturer (+201061403338, walaa95.hamdy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative acute kidney injury (AKI) based on the KDIGO criteria. (time frame: Assessed at the third postoperative day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.