Materials and Methods:• Study design: Prospective observational study• Study period:(i) Period needed for collecting data: 2 months(ii) Period required for analyzing the data: 1 month• Inclusion criteria: o Patients with seizures who are admitted within 24 hours of the seizure event.o Patients who have been treated with Levetiracetam or Phenytoin.o Patients above the age of 18 years.• Exclusion criteria: o Patients below the age of 18 yearso Patients admitted after 24 hours of seizure episodeo Pseudo seizure ( PNES )o Patients who have received an IM injection o Patients who have been treated with other Anti-Epileptic drugs apart from Levetiracetam and Phenytoin.o Patients who have been admitted due to POLY TRAUMA.• Sample Size with Proper Justification:o Sample size: 98• According to a study performed by Javali et al (2017), out of 100 patients subjected to study 36% of the patients presented with generalized tonic–clonic seizures (GTCS). The next common presentation was simple partial seizures (29%), complex partial seizures (CPS) (19%), and status epilepticus (SE) (7%) at admission.
9% of patients were retrospectively diagnosed to have PNES using video-EEG. Nearly 91.66% of patients with GTCS who presented within 1 h had elevated CK whereas 70% of patients with partial seizures had elevated Total CK.• In the present study expecting similar proportion; considering absolute precision of 8%; to achieve a desired confidence level of 95%; the sample size worked out to 98 epileptic patients.Detailed Description of Procedure:-? Selection of Subjects :- 98 Consecutive patients belonging to the inclusion criteria and admitted to Ramaiah Memorial Hospital? Biochemical estimate Required :- Total Creatine Kinase (CK) level.
? Process of acquiring total CK ( Creatine Kinase ) level :-Reports of Serum Creatine Kinase (CK) done as a part of the standard patient management protocol in epilepsy (seizure) will be accessed and values will be recorded.Serum Creatine Kinase (CK) is done on Roche Cobas 6000 analyser by enzymatic colorimetric method in the diagnostic laboratories in Ramaiah Memorial hospital.? Number of samples to be collected:- For every subject included in the study a minimum of 3-4 consecutive serum total CK values will be recorded till the post ictal phase is attained and the total CK level comes back to normal level.• Place of Study: – Ramaiah Memorial Hospital• Investigations: – Total Creatine Kinase Level• Potential Risks and Benefits: -a. The blood sample collected as a part of the routine investigations for Seizure (Epilepsy) would be used in this study. Hence there is no introduction of any additional risks.b.
By conducting this study, we intend to provide scope for a further study on Creatine Kinase as it is clinically very important in the field of Diagnosis and Prognosis of Epilepsy.• Statistical Methods:-o Descriptive Statistics of values of Total Creatine Kinase (CK) will be analyzed and summarized in terms of percentage.o The values of Total Creatine Kinase (CK) in comparison with the time of exhibition will be analyzed and summarized in pictorial representations using valid Graphs.o Chi-Square test would be used to compare Total Creatine Kinase (CK) normalization between different age groups and sex.• Ethical Considerations and Methods to Address Issues:- A written informed consent form would be provided to the participants. The participants will be informed about the procedure before collection of the Total Creatine Kinase ( CK ) values .• Implications of the study:-o The research focusses on yielding a result that enables us to understand the relationship between Total Creatine Kinase (CK) level and Seizures.o The research enables us to predict and prevent Drug Induced Seizures and in turn act as a precautionary entity.o The research aims to intervene with the very fundamental aspects of drug prescription and its interaction in the patient with a system of epileptic disorders .• Budget and proposed funding source:- NIL