Effect of Different Anesthetic Drugs on Electrocorticography (ECOG). (ECOG-Anaes)

Effect of Different Anesthetic Drugs on Electrocorticography (ECOG), Randomized Controlled Double-blinded Study

Prospective, double-blind, randomized-controlled study for pediatric cases scheduled for brain tumor excision with the aid of electrocorticography (ECOG). Intraoperative ECOG has been used in an effort to localize the site of epileptogenicity through the demonstration of Interictal Epileptiform Discharges (IED) persistence, frequency, and distribution. During ECOG, pharmaco-activation may be required in order to activate Interictal Epileptiform Abnormalities (IEAs). Frequency of IEAs will be measured for each drug.

The effects of anesthetic agents on intraoperative ECOG, as we assume that fentanyl will be superior to ketamine.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy; Brain Tumor
• Intervention / Treatment: Drug: Fentanyl (IV); Drug: Ketamine (0.5 mg/kg)

Detailed Description

Brain tumors can be responsible for epilepsy refractory to medical therapy. These are typically slow-growing tumors, and surgery aims to cure the patient's seizure disorder. One of the main uses of electrocorticography is mapping the cortical regions associated with epileptiform activity. This information is used to plan resection boundaries. Electroencephalography (EEG) electrodes are placed directly on the cortical surface, and epileptiform activity is identified, and this can guide the extent of resection. This technique is referred to as intraoperative electrocorticography (IOECOG).

IOECOG has been used to localize the site of epileptogenicity through the demonstration of Interictal Epileptiform Discharges (IED) persistence, frequency, and distribution. As the intraoperative time is short, clinical seizures are usually not captured by ECOG, but the presence and location of IEAs can be used to localize the epileptogenic focus and guide the resection.

During ECOG, pharma coactivation may be required to activate IEAs. Fentanyl and ketamine can be used for this

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11617
    • Children Cancer Hospital 57357
  • Cairo, Egypt, 11511
    • Children's Cancer Hospital Egypt 57357

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age (2-18) Years scheduled for brain tumor excision with aid of ECOG
• ASA physical status (II-III).
• Patient undergoing brain surgery with epileptic focus.

Exclusion Criteria:

• guardian refusal.
• Patients with hypertension, ischemic heart disease, arrhythmia, or respiratory or renal dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl; fentanyl will be used as bolus (1 µg/kg) for spike stimulation	Drug: Fentanyl (IV); Fentanyl, Intravenous bolus administration at a dose of 1 microgram per kilogram of body weight administered once before spike stimulation and another time after resection of epileptic foci for spike stimulation.; Other Names: fentanyl citrate
Experimental: Ketamine; ketamine will be used (0.5 mg/kg) for spike stimulation	Drug: Ketamine (0.5 mg/kg); Ketamine, Intravenous bolus administration at a dose of 0.5 milligram per kilogram of body weight administered once before spike stimulation and another time after resection of epileptic foci for spike stimulation.; Other Names: ketamine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG	The frequency of spikes will be recorded at baseline (before using the drug) and after using the drug before resection. After resection of the epileptic foci, restimulation with the drug will be done and spikes will be recorded.	18 months
Effect of fentanyl and ketamine on amplitude of the spikes activated during intraoperative ECOG.	The amplitude of spikes will be recorded at baseline (before using the drug) and after using the drug before resection. After resection of the epileptic foci, restimulation with the drug will be done, and the spike amplitude will be recorded.	18-month
Effect of fentanyl and ketamine on number of leads with activated spikes during intraoperative ECOG.	The number of leads with activated spikes will be recorded at baseline (before using the drug) and after using the drug before resection. After resection of the epileptic foci, restimulation with the drug will be done, and the number of leads with activated spikes will be recorded.	18-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of fentanyl and ketamine on blood pressure is to be measured with the drug administered for stimulation.	The effect of fentanyl and ketamine on blood pressure will measured pre- and post-drug administration.	18 months
The effect of fentanyl and ketamine on heart rate is to be measured with the drug administered for stimulation.	The effect of fentanyl and ketamine on heart rate will be measured pre- and post-drug administration.	18-month
The effect of fentanyl and ketamine on recovery time.	The effect of fentanyl and ketamine on recovery time will be measured.	18 month

Collaborators and Investigators

• Sponsor: Children's Cancer Hospital Egypt 57357
• Investigators: Principal Investigator: Suzan A. Abdelrahman, consultant, Children's Cancer Hospital Egypt 57357

Publications and helpful links

General Publications

• Lemieux, L., et al. (2012). "Invasive EEG for Epilepsy Surgery: Current Techniques and Considerations." Journal of Clinical Neurophysiology, 29(3), 246-257.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 24, 2025
• First Submitted That Met QC Criteria: September 7, 2025
• First Posted (Estimated): September 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: ECOG, Brain Tumors, Ketamine, Fentanyl
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Epilepsy; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Piperidines; Ketamine; Fentanyl
• Other Study ID Numbers: N-0061-008-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No