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Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors :RCT-Single Blind

Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors:RCT-Single Blind

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150419021837N1
Enrollment
80
Registered
2017-12-19
Start date
2016-09-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Comparison of Effectiveness of Levetiracetam With Phenytoin in Postcraniotomy Seizure in the Patients with Supratentorial Brain Tumors.

Interventions

Intervention 1: 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 500
Prevention
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 Ora
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 O

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

Exclusion criteria: History of Allergy to the Two Drugs,History of Seizere,Posterior Fossa Tumors,Pregnancy&History of Colostomy

Design outcomes

Primary

MeasureTime frame
Siezure. Timepoint: Days of 7,30&90 Post Craniotomy. Method of measurement: Observation by the nurse or physicion.

Secondary

MeasureTime frame
Complications of Skin ,Renal&Liver. Timepoint: Days of 7,30&90 Post Craniotomy. Method of measurement: Observation of Skin &Liver&Renal lab data.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Abolfazli

Tehran University of Medical Sciences

mehdiabolfali1366@gmail.com+98 21 8490 2272

Outcome results

None listed

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