EpilepsyPhase 3ECOG-AnaesNCT07165262
Effect of Different Anesthetic Drugs on Electrocorticography (ECOG).
A Phase 3 study testing Fentanyl (IV) and Ketamine (0.5 mg/kg) in people with Epilepsy and Brain Tumor, run by Children's Cancer Hospital Egypt 57357 at 2 sites in Egypt.
Trial 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)… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy, Brain Tumor
- What is being tested?
- Fentanyl (IV) and Ketamine (0.5 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Aug 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- guardian refusal.
- Patients with hypertension, ischemic heart disease, arrhythmia, or respiratory or renal dysfunction.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Children's Cancer Hospital Egypt 57357
Cairo, 11511
Children Cancer Hospital 57357
Cairo, 11617
About this study
Official title: Effect of Different Anesthetic Drugs on Electrocorticography (ECOG), Randomized Controlled Double-blinded Study
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.
Read the 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
- Epilepsy, Brain Tumor
- Being tested
- Fentanyl (IV), Ketamine (0.5 mg/kg)
- Keywords
- ECOG, Brain Tumors, Ketamine, Fentanyl
- Medical subject headings
- Epilepsy, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (IV)Drug
Also called fentanyl citrate
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 (0.5 mg/kg)Drug
Also called ketamine hydrochloride
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.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | fentanyl will be used as bolus (1 µg/kg) for spike stimulation Receives: Drug: Fentanyl (IV) |
| Ketamine | Experimental | ketamine will be used (0.5 mg/kg) for spike stimulation Receives: Drug: Ketamine (0.5 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18-months
Secondary outcomes (3)
The effect of fentanyl and ketamine on blood pressure is to be measured with the drug administered for stimulation.
The effect of fentanyl and ketamine on blood pressure will measured pre- and post-drug administration.
Measured: 18 months
The effect of fentanyl and ketamine on heart rate is to be measured with the drug administered for stimulation.
The effect of fentanyl and ketamine on heart rate will be measured pre- and post-drug administration.
Measured: 18-month
The effect of fentanyl and ketamine on recovery time.
The effect of fentanyl and ketamine on recovery time will be measured.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start18 Aug 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzan A. Abdelrahman, consultant, Principal investigator, Children's Cancer Hospital Egypt 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165262
- Sponsor's protocol ID
- N-0061-008-025
- Acronym
- ECOG-Anaes
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemieux, L., et al. (2012). "Invasive EEG for Epilepsy Surgery: Current Techniques and Considerations." Journal of Clinical Neurophysiology, 29(3), 246-257.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Anesthetic Drugs on Electrocorticography (ECOG), Randomized Controlled Double-blinded Study
- ClinicalTrials.gov ID
- NCT07165262
- Acronym / sponsor ID
- ECOG-Anaes / N-0061-008-025
- Conditions
- Epilepsy, Brain Tumor
- Keywords
- ECOG, Brain Tumors, Ketamine, Fentanyl
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: Fentanyl (IV)fentanyl will be used as bolus (1 µg/kg) for spike stimulation |
| Ketamine | Experimental | Drug: Ketamine (0.5 mg/kg)ketamine will be used (0.5 mg/kg) for spike stimulation |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- guardian refusal.
- Patients with hypertension, ischemic heart disease, arrhythmia, or respiratory or renal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl (IV)Also: fentanyl citrateFentanyl, 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 | Fentanyl |
| Ketamine (0.5 mg/kg)Also: ketamine hydrochlorideKetamine, 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. | Drug | Ketamine |
Primary outcome
Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG
Time frame: 18 months
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.
Effect of fentanyl and ketamine on amplitude of the spikes activated during intraoperative ECOG.
Time frame: 18-month
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.
Effect of fentanyl and ketamine on number of leads with activated spikes during intraoperative ECOG.
Time frame: 18-months
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.
3 secondary outcomes
The effect of fentanyl and ketamine on blood pressure is to be measured with the drug administered for stimulation.
Time frame: 18 months
The effect of fentanyl and ketamine on heart rate is to be measured with the drug administered for stimulation.
Time frame: 18-month
The effect of fentanyl and ketamine on recovery time.
Time frame: 18 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Results publicationLemieux, L., et al. (2012). "Invasive EEG for Epilepsy Surgery: Current Techniques and Considerations." Journal of Clinical Neurophysiology, 29(3), 246-257.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan A. Abdelrahman, consultant principal investigator
Children's Cancer Hospital Egypt 57357
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl (IV) and Ketamine (0.5 mg/kg) in people with Epilepsy and Brain Tumor, run by Children's Cancer Hospital Egypt 57357 at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.