1.Reference ID:- 2018-02621 2.
Title:- STUDY OF TOTAL CREATINE KINASE (CK)LEVEL IN PATIENTS WITH SEIZURES AND THE EFFECT OF ANTI-EPILEPTIC DRUGS ON TOTALCREATINE KINASE (CK) LEVEL. 3.Introduction:- Epilepsy is the 4th mostcommon neurological problem. In India morethan 1 million cases of epilepsy are recorded every year. Even though CreatineKinase (CK) is evidently the most accessible parameter that can effectivelyhelp us learn more about seizures there has not been significant amount ofresearch enabling us to understand the same.Aseizure represents the clinical expression of abnormal, excessive, synchronousdischarges of neurons residing primarily in cerebral cortex. Epilepsyconsidered to be a disease of the brain defined by any of the followingconditions: (1) At least, two unprovoked (or reflex)seizures occurring >24 h apart; (2) one unprovoked (orreflex) seizure and a probability of further seizures similar to the generalrecurrence risk (at least 60%) after two unprovoked seizures, occurring overthe next 10 years; (3)diagnosis of an epilepsy syndrome.Creatine Kinase has been a standardinvestigating parameter in the field of seizures (Epilepsy).
The currentresearch focuses primarily in understanding the relationship between Total CKand seizures and in turn assessing the intricate details of the same. Theagenda for the current research study has been to effectively assess the role ofTotal CK in seizures and in turn evaluate the pharmacological effects ofvarious anti-epileptic drugs used in order to manage the medical condition ofseizures. As CK is also a direct indicator of extent of rhabdomyolysis thestudy aims to predict and prevent acute renal failure and in turn act as aprecautionary entity for the same. The research aims to intervene with the veryfundamental aspects of drug prescription and its interaction in the patientwith a system of epileptic disorders.
On extraction of the required data(Total CK values of a seizure patient over a course of time), I shallsystematically plot it over a graph comparing its quantity and time ofexhibition. The values collected involve the patient who is already diagnosedwith at least one or two episodes of seizure. The values collected involve theassessment of patient’s prognosis over the anti-epileptic drug used in order tomanage the condition.Thus, the current research focuses primarily inunderstanding the relationship between Total CK and seizures and in turnassessing the intricate details of the same. The agenda for the currentresearch study has been to effectively assess the role of Total CK in seizures.
4.Objectives:-1. To study the relationship betweenseizures and Total Creatine Kinase.2.
To study the effect of Phenytoinvs Levetiracetam on Total CK Level.3. To identify and present thesequential changes in the values of Total CK during the course of treatment of a Seizure. 5.
Methodology:-? Study design: Prospective Observational Study? Study period: 2 months? Inclusion criteria: o Patientswith seizures who are admitted within 24 hours of the seizure event.o Patientswho have been treated with Levetiracetam or Phenytoin.o Patientsabove the age of 18 years. ? Exclusion criteria: o Pseudoseizure ( PNES )o Patientswho have received an IM injection o Patients suffering from primary muscledisorders like muscular dystrophies.o Athletes They tend to have higher CreatineKinase (CK) levels o Patientswho have been treated with other Anti-Epileptic drugs apart from Levetiracetamand Phenytoin.o Patientswho have been admitted due to POLY TRAUMA.
? Sample Size with Proper Justification:Ø Sample size: 98? According to a study performed byJavali et al (2017), out of 100 patients subjected to study 36% of the patients presented withgeneralized tonic–clonic seizures (GTCS). The next common presentation wassimple partial seizures (29%), complex partial seizures (CPS) (19%), and statusepilepticus (SE) (7%) at admission. 9% of patients were retrospectivelydiagnosed to have PNES using video-EEG. Nearly 91.66% of patients with GTCS whopresented within 1 h had elevated CK whereas 70% of patients with partialseizures had elevated Total CK. ? In the present study expecting similar proportion;considering absolute precision of 8%; to achieve a desired confidence level of95%; the sample size worked out to 98 epileptic patients. ØDetailed Description of Procedure:-? Selection of Subjects :- 98 Consecutive patients belonging tothe inclusion criteria and admitted to Ramaiah Memorial Hospital? Biochemical estimate Required :- TotalCreatine 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 doneon Roche Cobas 6000 analyser by enzymatic colorimetric method in the diagnosticlaboratories in Ramaiah Memorial hospital. ? Number of samples to be collected:- Ø The Anti-Epileptic drug used for thetreatment of the condition is noted down for every subject.Ø For every subject included in thestudy a minimum of 3-4 consecutive serum total CK values will be recorded tillthe post ictal phase is attained and the total CK level comes back to normallevel.
? Place of Study: – RamaiahMemorial Hospital? Investigations:-Total Creatine Kinase Level ? Potential Risks and Benefits: -a. The blood sample collected as a partof the routine investigations for Seizure (Epilepsy) would be used in thisstudy. Hence there is no introduction of any additional risks.b. By conducting this study, we intendto provide scope for a further study on Creatine Kinase as it is clinicallyvery important in the field of Diagnosis and Prognosis of Epilepsy. ? Statisticalmethods:-o Descriptive Statistics of values ofTotal Creatine Kinase (CK) will be analyzed and summarized in terms ofpercentage.o The values of Total Creatine Kinase (CK) in comparison withthe time of exhibition will be analyzed and summarized in pictorialrepresentations using valid Graphs.o Chi-Square test would be used to compare Total Creatine Kinase (CK) normalization between different agegroups and sex.
? Ethicalconsiderations:-A written informed consent form would be provided to theparticipants. The participants will be informed about the procedure beforecollection of the Total Creatine Kinase (CK) values. 6.
Implications:- o The research focusses on yielding aresult that enables us to understand the relationship between Total CreatineKinase (CK) level and Seizures.o The research enables us to Predictand Prevent Drug Induced Seizures and in turn act as a precautionary entity.o The research aims to intervene withthe very fundamental aspects of drug prescription and its interaction in thepatient with a system of epileptic disorders. 7. References:-1. Mahendra Javali, Purushottam Acharya, Shripal Shah.
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