Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors:RCT-Single Blind
Comparison of the Effectiveness of the Phenytoin with the Levetiracetam on Pre&Postcraniotomy Seizure in the Supratentorial Brain Tumors Patients.
Design
The study is randomized clinical trials that include the patients with defenitive diagnosis of supratentorial brain tumors&need to craniotomy.After entrance, the patients arrangements by randomization with proportion 1:1 in two groups of Phenytoin&Levetiracetam.The block randomization is used in the study.Seizure after onset of drugs or drug complications are on the ground of treatment failure.The two groups compare together.In the study exist extent of tumor resection,postop edema&hematoma,maximum of the brain mass diameter,pathology&duration of the surgery.before onset of the study,the purposes&type of the study&form of performance explain to the patients&get written consent from the patients for play at the study.the numbers of every group is 40&clinical trial phase is 3.
Settings and conduct
the location of the study is shariati hospital&the study is single blind.the examiner is blind.
Participants/Inclusion and exclusion criteria
The patients with age higher from 18years with Supratentorial Tumors need to Craniotomy&Liver & Renal function,Creatinine lower from1.5× upper limit of normal (ULN), Aspartate Aminotransferase lower from3× ULN, Alanine Aminotransferase lower from 3× ULN and Bilirubin lower from1.5× ULN).Exclusion criterias are history of seizure before onset the drugs,skin complications,concurent of skull tumor&brain events examples CVA(Cerebrovascular Accident)&injury of the truma&infratentorial tumors.Advantages & disadvantages of use of AED(Antiepilectic Drugs) explain to the patients that have not history of seizure before onset the prophilactic treatment.Also other exclusion critrias are history of Allergy to the Two Drugs,History of Seizere,Posterior Fossa Tumors,Pregnancy&History of Colostomy.
Intervention groups
One group receives the Phenytoin&another receives the levetiracetam.The complications check in every group.
Main outcome variables
The Seizure,Skin,Renal & Liver complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150419021837N1
Registration date:2017-12-19, 1396/09/28
Registration timing:registered_while_recruiting
Last update:2017-12-19, 1396/09/28
Update count:0
Registration date
2017-12-19, 1396/09/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2272
Email address
m-faghihj@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors:RCT-Single Blind
Public title
Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors :RCT-Single Blind
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with age higher from 18years with Supratentorial Tumors need to Craniotomy&Liver & Renal function,Creatinine lower from1.5× upper limit of normal (ULN), Aspartate Aminotransferase lower from3× ULN, Alanine Aminotransferase lower from 3× ULN and Bilirubin lower from1.5× ULN)
Exclusion criteria:
History of Allergy to the Two Drugs,History of Seizere,Posterior Fossa Tumors,Pregnancy&History of Colostomy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner does not know use which Drugs(Levetiracetam or Phenytoin)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
North karegar Ave,Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
9311255001
Health conditions studied
1
Description of health condition studied
Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
siezure
Timepoint
Days of 7,30&90 Post Craniotomy
Method of measurement
Observation by the nurse or physicion
Secondary outcomes
1
Description
Complications of Skin ,Renal&Liver
Timepoint
Days of 7,30&90 Post Craniotomy
Method of measurement
Observation of Skin &Liver&Renal lab data
Intervention groups
1
Description
Intervention group: Prophylaxis of the drugs use begins from 5 days before the surgery to continues 90 days after the surgery.Levetiracetam Dosage:1gr Bid in the operation day then 500mg Bid IV OR Oral
Category
Prevention
2
Description
Intervention group: Prophylaxis of the drugs use begins from 5 days before the surgery to continues 90 days after the surgery.Phenytoin dosage:loading dose10-15 mg /kg IV-maintenance 100mg tds IV OR Oral.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Medi Abolfazli
Street address
North Karegar AVE-Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2272
Email
mfaghihj@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
North karegar Ave,Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2272
Email
m-faghihj@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Abolfazli
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
North karegar Ave,Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2272
Email
mehdiabolfali1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Faghih Jouybari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
North Karegar,Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2272
Email
m-faghihj@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Abolfazli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
North Karegar,Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2272
Email
mehdiabolfazli1366@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of data of practicipants
When the data will become available and for how long
6month after publication of results
To whom data/document is available
Researchers of university&scientific institues.
Under which criteria data/document could be used
In case of requesting the results
From where data/document is obtainable
TO me
What processes are involved for a request to access data/document