| CTRI Number |
CTRI/2020/03/024133 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study role of one vs two anti epileptic drugs in post awake craniotomy patients |
|
Scientific Title of Study
|
Randomized trial to assess the efficacy of single vs two anti epileptic drugs for patients undergoing awake craniotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Thakur |
| Designation |
Junior Resident |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room No. 720
Department of Neurosurgery
Neurosciences Centre
AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7807393730 |
| Fax |
|
| Email |
drashducati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G D Satyarthee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room No.720
Department of Neurosurgery
Neurosciences Centre
AIIMS
New Delhi
Central
DELHI
110029
India |
| Phone |
9654398900 |
| Fax |
|
| Email |
drguruduttaaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Tandon |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room No.720
Department of Neurosurgery
Neurosciences Centre
AIIMS
New Delhi
Central
DELHI
110029
India |
| Phone |
8882466677 |
| Fax |
|
| Email |
drtandonvivek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurosurgery
Neurosciences Centre
AIIMS
New Delhi
|
|
|
Primary Sponsor
|
| Name |
Dr Vivek Tandon |
| Address |
Room No.720
Department of Neurosurgery
Neurosciences Centre
AIIMS
New Delhi
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Tandon |
AIIMS , New Delhi |
Room No.720
Department of Neurosurgery
Neurosciences Centre
New Delhi
New Delhi
DELHI |
9868398470
drtandonvivek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research(Clinical Science), AIIMS , New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SINGLE ANTIEPILEPTIC |
PATIENT TO FOLLOW THE DOSE AND REGIMEN OF DRUG AS BEING FOLLOWED IN PREOPERATIVE PERIOD, IF SEIZURES UNDER CONTROL. IF SEIZURES ARE NOT UNDER CONTROL THEN NEUROLOGY CONSULTATION TO BE SOUGHT AND THEIR ADVISE TO BE FOLLOWED.If the treating physicians feels the need to give a single or double drug contrary to the randomized arm due to clinical condition of the patient then patient will be analyzed as per the intention to treat analysis protocol. |
| Intervention |
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 PHENYTOIN THEN LEVETIRACETAM WILL BE ADDED AND IF ON PHENYTOIN THEN LEVETIRACETAM WILL BE ADDED.PATIENT TO FOLLOW THE DOSE AND REGIMEN OF 1ST DRUG AS BEING FOLLOWED IN PREOP PERIOD IF SEIZURES UNDER CONTROL. IF SEIZURES ARE NOT UNDER CONTROL THEN NEUROLOGY CONSULTATION TO BE SOUGHT AND THEIR ADVISE TO BE FOLLOWED.If the treating physicians feels the need to give a single or double drug contrary to the randomized arm due to clinical condition of the patient then patient will be analyzed as per the intention to treat analysis protocol. Following regimen to be followed for 2nd drug:
If 2nd drug is Phenytoin:
• on the day of surgery (day 1) :750 mg iv infusion for 1 hour before entering the operating room, and another 720mg then continued for 24 hours (at 30 mg/hour). Total of 1470mg dose on day1
• on day 2 : i.v.Phenytoin 100 mg tid infusion at rate of 30mg/hr if patient can accept orally then Tablet phenytoin will be given (100 mg TDS or 300 mg HS)
• on day 3:i.v. /p.o. Phenytoin 50 mg tid;
• on day 4:i.v./p.o. Phenytoin 50 mg bd;
• on day 5: i.v./p.o. Phenytoin 50 mg o.d.
If 2nd drug is Levetiracetam:
• on day 1: i.v. Levetiracetam infusion 1000 mg within 20minutes at a rate of 50mg/min before entering the operating room and same dose repeated in the evening
• on day 2 i.v. Levetiracetam infusion 1000 mg bd;
• on day 3, i.v. /p.o.Levetiracetam 500mg bd;
• 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 compared to phenytoin for the prevention of postoperative seizures after craniotomy for intracranial tumours in patients without epilepsy. Journal of Clinical Neuroscience. 2012;19(1):99-100. doi:10.1016/j.jocn.2011.07.021
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
TIME OF ADMISSION TO POST OPERATIVE DAY 5 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="11"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
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 |