Effect of Different Anesthetic Drugs on Electrocorticography (ECOG), Randomized Controlled Double-blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •guardian refusal.
- •Patients with hypertension, ischemic heart disease, arrhythmia, or respiratory or renal dysfunction.
研究组 & 干预措施
Fentanyl
fentanyl will be used as bolus (1 µg/kg) for spike stimulation
干预措施: Fentanyl (IV) (Drug)
Ketamine
ketamine will be used (0.5 mg/kg) for spike stimulation
干预措施: Ketamine (0.5 mg/kg) (Drug)
结局指标
主要结局
Effect of fentanyl and ketamine on frequency of spike activation during intraoperative ECOG
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- The effect of fentanyl and ketamine on blood pressure is to be measured with the drug administered for stimulation.(18 months)
- The effect of fentanyl and ketamine on heart rate is to be measured with the drug administered for stimulation.(18-month)
- The effect of fentanyl and ketamine on recovery time.(18 month)