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

NCT06753409 | Recruiting DMC

• 1 other identifier: EEG-Guided General Anesthesia
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Acute Kidney Injury

Keywords

Hypotension; Abdominal surgery; Norepinephrine; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at the third postoperative day.

Secondary Outcomes (2)

• 1.Total dose of norepinephrine administrated

  48 hour

• 2.The volume of intraoperative fluid therapy.

  48 hour

Study Arms (2)

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.

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.

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

Interventions

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.

pEEG-Guided General Anesthesia Group

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.

Non-pEEG-Guided Anesthesia (Standard Care Group) with blinded pEEG monitoring

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Walaa H Mohamed, Assistant Lecturer

CONTACT

+201061403338; walaa95.hamdy@gmail.com

Mostafa S Abbas, Professor

CONTACT

+201003060187; mostafasamy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 31, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)