Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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

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Epilepsy Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fentanyl

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

Group Type ACTIVE_COMPARATOR

Fentanyl (IV)

Intervention Type 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.

Ketamine

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

Group Type EXPERIMENTAL

Ketamine (0.5 mg/kg)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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fentanyl citrate ketamine hydrochloride

Eligibility Criteria

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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.