Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

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Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07165262
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Cancer Hospital Egypt 57357
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Suzan A. Abdelrahman, consultant
Principal Investigator Affiliation	Children's Cancer Hospital Egypt 57357
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Epilepsy, Brain Tumor

Additional Details

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

Arms & Interventions

Arms

Active Comparator: Fentanyl

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

Experimental: Ketamine

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

Interventions

Drug: - 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.

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.

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International Sites

Children's Cancer Hospital Egypt 57357, Cairo 360630, Egypt

Status

Address

Children's Cancer Hospital Egypt 57357

Cairo 360630, , 11511

Children Cancer Hospital 57357, Cairo 360630, Egypt

Status

Address

Children Cancer Hospital 57357

Cairo 360630, , 11617

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