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Active Not RecruitingNCT07165262

Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

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

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Children's Cancer Hospital Egypt 57357 · Academic / Other
Sex
All
Age
2 Years – 18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGFentanyl (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.
DRUGKetamine (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.

Timeline

Start date
2025-08-18
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2025-09-10
Last updated
2025-09-10

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07165262. Inclusion in this directory is not an endorsement.