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A study to understand how Levetiracetam is prescribed and its side effects in patients taking it to prevent seizures after brain surgery

Assessment of Prescription Pattern and Adverse Drug Reaction Monitoring of Levetiracetam Used for Seizure Prophylaxis in Patients following Neurosurgery: A Cross-Sectional, Questionnaire-Based Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096443
Enrollment
200
Registered
2025-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: NIl: NIl Control Intervention1: Nil: Nil

Sponsors

Dr. Padmaja Marathe
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 12 years or above of either sex. Patients who have undergone neurosurgery and are prescribed levetiracetam for seizure prevention for at least one month.

Exclusion criteria

Exclusion criteria: Patients who are known cases of epilepsy and receiving one or more anti-epileptic drugs before surgery for the same. • Patients or LAR who are unwilling or unable to provide informed consent. • Critically ill patients who had prolonged hospitalization due to intra op/post op complications due to neurosurgery. • Patient on any anti-psychotics or anti-depressants or with previous history of pyschosis /depression. • Patient with family history of psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
To assess the prescription pattern in patients given levetiracetam for seizure prophylaxis for one month or more following neurosurgeryTimepoint: To assess the prescription pattern in patients given levetiracetam for seizure prophylaxis for one month or more following neurosurgery—

Secondary

MeasureTime frame
To identify neuro-psychiatric adverse effects in patients receiving levetiracetam for seizure prophylaxis post-neurosurgery. b) To establish casualty between neuro-psychiatric adverse effects and levetiracetam prophylaxis c) To identify other adverse drug reactions to levetiracetam therapy in patients receiving levetiracetam for seizure prophylaxis d) To correlate the plasma levels of levetiracetam with neuro-psychiatric adverse effects in patients who have been advised therapeutic drug monitoring. 4.Timepoint: at the end of study—

Countries

India

Contacts

Public ContactDr Padmaja Marathe

Department of Pharmacology and therapeutics , Seth Gs Medical College and kem Hospital,Parel,mumbai

rajbaxi98@gmail.com9619466099

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026