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Active, Not Recruiting

NCT Number: NCT07165262

Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children Cancer Hospital 57357, Cairo, Egypt

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl (IV)

Drug

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

Ketamine (0.5 mg/kg)

Drug

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

Primary outcomes

  1. Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG

    Time frame: 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.

  2. Effect of fentanyl and ketamine on amplitude of the spikes activated during intraoperative ECOG.

    Time frame: 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.

  3. Effect of fentanyl and ketamine on number of leads with activated spikes during intraoperative ECOG.

    Time frame: 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 outcomes

  1. The effect of fentanyl and ketamine on blood pressure is to be measured with the drug administered for stimulation.

    Time frame: 18 months

    The effect of fentanyl and ketamine on blood pressure will measured pre- and post-drug administration.

  2. The effect of fentanyl and ketamine on heart rate is to be measured with the drug administered for stimulation.

    Time frame: 18-month

    The effect of fentanyl and ketamine on heart rate will be measured pre- and post-drug administration.

  3. The effect of fentanyl and ketamine on recovery time.

    Time frame: 18 month

    The effect of fentanyl and ketamine on recovery time will be measured.

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

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

Acronym: ECOG-Anaes

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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