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Clinical Trials in Egypt / NCT07165262
Active, not recruiting Phase 3

Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

NCT07165262 · tracked via the Priya Life Science Egypt tracker
Sponsor
Children's Cancer Hospital Egypt 57357
Phase
Phase 3
Started
2025-08-18
Last updated
2025-09-10

Condition(s) studied

EpilepsyBrain Tumor

Investigational drug(s) / intervention(s)

Fentanyl (IV) →Ketamine (0.5 mg/kg) →

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
Children's Cancer Hospital Egypt 57357 Cairo Egypt
Children Cancer Hospital 57357 Cairo Egypt

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Other trials for the same condition

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This Study Will Assess the Etiology, Potential Risk Factors, and Seizure Types in Patients Over 50 With Epileptic Seizure Disorder, Using Laboratory Tests, EEG, and Neuroimaging Findings. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07165262 on ClinicalTrials.gov ↗ ← All trials in Egypt