Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system
Conditions
Interventions
Intervention1: TWO ANTI EPILEPTICS: PATIENTS RANDOMIZED TO TWO ANTI EPILEPTIC ARM WILL BE GIVEN ADDITIONAL ANTI EPILEPTIC, EITHER PHENYTOIN OR LEVETIRACETAM . IF PREOPERATIVELY PATIENT IS ON PHENYTO
â?¢ on day 4:i.v./p.o. Phenytoin 50 mg bd
â?¢ on day 5: i.v./p.o. Phenytoin 50 mg o.d.
If 2nd drug is Levetiracetam:
â?¢ on day 1: i.v. Levetiracetam infusion 1000 mg within 20minutes at a rate of 50mg/min before entering the operating roo
â?¢ on day 3, i.v. /p.o.Levetiracetam 500mg bd
â?¢ on days 4 and 5, , i.v. /p.o.Levetiracetam 500mg o.d
The above regimen has been designed by referring to below mentioned article:
Kern K, Schebesch KM, Schlaier J, et al. Levetiracetam
Sponsors
Dr Vivek Tandon
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: a) Age b) Pregnant females c) Patients on Preoperative duo therapy d) Allergic to phenytoin or levetiracetam e) Patient unwilling to enroll in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: TIME OF ADMISSION TO POST OPERATIVE DAY 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| ANALYSE THE INCIDENCE OF INTRA OPERATIVE SEIZURES IN TWO GROUPS OF PATIENTSTimepoint: INTRAOPERATIVE PERIOD;CORELATION WITH ELOQUENT AREA, TUMOR HISTOPATHOLOGY, IMMUNOCYTOCHEMISTRY AND DEGREE OF RESECTIONTimepoint: 3RD MONTH OF FOLLOW UP | — |
Countries
India
Contacts
Public ContactDr Vivek Tandon
AIIMS,New Delhi
Outcome results
None listed