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

NCT ID: NCT06753409

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-01-01

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

pEEG-Guided General Anesthesia Group

Depth of anesthesia will be managed based on pEEG monitoring using Entropy with a target range of 40-60.

Group Type: ACTIVE_COMPARATOR

Processed electroencephalography (pEEG) Guided General Anesthesia

Intervention Type: 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 Anesthesia (Standard Care Group) with blinded pEEG monitoring

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

Group Type: PLACEBO_COMPARATOR

Non-pEEG-Guided General Anesthesia (with blinded pEEG monitoring)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

walaa hamdy mohamed hemaid

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospitals

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Walaa H Mohamed, Assistant Lecturer

Role: CONTACT

walaa95.hamdy@gmail.com

+201061403338

Mostafa S Abbas, Professor

Role: CONTACT

mostafasamy@aun.edu.eg

+201003060187

Facility Contacts

Vice president of graduate studies of Assiut University

Role: primary

vp_grad@aun.edu.eg

+2088 22080

Other Identifiers

EEG-Guided General Anesthesia

Identifier Type: -

Identifier Source: org_study_id