Effect of Different Anesthetic Drugs on Electrocorticography (ECOG). (ECOG-Anaes)

Children's Cancer Hospital Egypt 57357

Status and phase: Active, not recruiting; Phase 3

Conditions: Epilepsy; Brain Tumor

Treatments: Drug: Fentanyl (IV); Drug: Ketamine (0.5 mg/kg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07165262

N-0061-008-025

Details and patient eligibility

About

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.

Full 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

Enrollment: 88 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Fentanyl

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl (IV)

Ketamine

Experimental group

Description:

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

Treatment:

Drug: Ketamine (0.5 mg/kg)