Randomized trial to assess the efficacy of single vs two anti epileptic drugs for patients undergoing awake craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- OCCURENCE OF EVEN A SINGLE EPISODE OF SEIZURE INTRAOPERATIVELY OR TILL POST OPERATIVE DAY 5 AS FAILURE OF TREATMENT AND NO SEIZURE AS SUCCESS OF TREATMENT.
研究概览
简要总结
AWAKE CRANIOTOMY IS REQUIRED FOR PATIENTS WITH LESIONS IN ELOQUENT CORTEX. DURING SURGERY OF THESE PATIENTS MANY REQUIRE NEUROMONITORING WHICH INVOLVES STIMULATING THE CORTEX. DUE TO THIS THERE IS A HIGH RISK OF DEVELOPING INTRA OPERATIVE SEIZURES . TRADITIONALLY MOST PATIENTS ARE GIVEN SAME ANTI EPILEPTIC DRUG, ON WHICH THEY WERE PREOPERATIVELY. THERE ARE VERY FEW STUDIES TO SHOW THAT GIVING TWO ANTIEPILETIC DRUGS CAN BE BENEFICIAL BUT LEVEL 1 EVIDENCE IS LACKING. WE PLAN TO UNDERTAKE THIS STUDY TO ESTABLISH THE EFFICACY OF SINGLE VS TWO ANTIEPILEPTIC DRUGS FOR PATIENTS UNDERGOING AWAKE CRANIOTOMY
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients undergoing awake craniotomy for glioma under neuromonitoring at our hospital between the time duration mentioned above b) Patients on preoperative antiepileptic monotherapy either phenytoin or levetiracetam.
排除标准
- •a) Age<18yrs b) Pregnant females c) Patients on Preoperative duo therapy d) Allergic to phenytoin or levetiracetam e) Patient unwilling to enroll in the trial.
结局指标
主要结局
OCCURENCE OF EVEN A SINGLE EPISODE OF SEIZURE INTRAOPERATIVELY OR TILL POST OPERATIVE DAY 5 AS FAILURE OF TREATMENT AND NO SEIZURE AS SUCCESS OF TREATMENT.
时间窗: TIME OF ADMISSION TO POST OPERATIVE DAY 5
次要结局
- ANALYSE THE INCIDENCE OF INTRA OPERATIVE SEIZURES IN TWO GROUPS OF PATIENTS(INTRAOPERATIVE PERIOD)
- CORELATION WITH ELOQUENT AREA, TUMOR HISTOPATHOLOGY, IMMUNOCYTOCHEMISTRY AND DEGREE OF RESECTION(3RD MONTH OF FOLLOW UP)