Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

NCT07165262 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: N-0061-008-025
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Brain Tumor

Keywords

ECOG, Brain Tumors, Ketamine, Fentanyl

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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 heart rate is to be measured with the drug administered for stimulation.

  18-month

• The effect of fentanyl and ketamine on recovery time.

  18 month

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

fentanyl will be used as bolus (1 µg/kg) for spike stimulation

Drug: Fentanyl (IV)

Ketamine

EXPERIMENTAL

ketamine will be used (0.5 mg/kg) for spike stimulation

Drug: Ketamine (0.5 mg/kg)

Interventions

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.

Also known as: fentanyl citrate

Fentanyl

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.

Also known as: ketamine hydrochloride

Ketamine

Eligibility Criteria

• Age: 2 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (2)

Children's Cancer Hospital Egypt 57357

Cairo, 11511, Egypt

Location

Children Cancer Hospital 57357

Cairo, 11617, Egypt

Location

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Epilepsy; Brain Neoplasms

Interventions

Fentanyl; Ketamine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Suzan A. Abdelrahman, consultant

  Children's Cancer Hospital Egypt 57357

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Signed consent will be obtained from all patient's guardian after a detailed preoperative explanation. 88 pediatric patients aged 2-18 years with brain tumor for excision with aid of ECOG and American Society of Anesthesiologist physical status II-III. Patients will be divided into two groups computer-allocated, given fentanyl (1ug/kg) and Ketamine (0.5mg/kg) for spike stimulation. Patients, anesthesiologists, surgeons, and neurophysiologist will be blinded to the group allocation of patients throughout the study. Spike frequency and waveform (pre-, during, and post-excision) intraoperatively will be recorded by the neurophysiologist which will be proportionate directly to the state of stimulation.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 10, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)