Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

Not Applicable

Active, not recruiting

• Conditions: Epilepsy; Brain Tumor
• Interventions: Drug: Fentanyl (IV); Drug: Ketamine (0.5 mg/kg)

• Registration Number: NCT07165262
• Lead Sponsor: Children's Cancer Hospital Egypt 57357

Brief Summary

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.

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 Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-18
• Study First Submitted: 2025-08-24
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2027-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl (IV)	fentanyl will be used as bolus (1 µg/kg) for spike stimulation
Ketamine	Ketamine (0.5 mg/kg)	ketamine will be used (0.5 mg/kg) for spike stimulation

Primary Outcome Measures

Name	Time	Method
Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG	18 months	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.
Effect of fentanyl and ketamine on amplitude of the spikes activated during intraoperative ECOG.	18-month	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.
Effect of fentanyl and ketamine on number of leads with activated spikes during intraoperative ECOG.	18-months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Children's Cancer Hospital Egypt 57357; 🇪🇬 Cairo, Egypt

Children Cancer Hospital 57357; 🇪🇬 Cairo, Egypt