Seizure Prophylaxis in Aneurysm Repair
Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliInatumika, sio kuajiri
Wadhamini
University of Michigan
JARIBIO LA KLINIKI: NCT01801072
BioSeek: NCT01801072
Maneno muhimu
Kikemikali
After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility.
Tarehe
| Imethibitishwa Mwisho: | 08/31/2019 |
| Iliyowasilishwa Kwanza: | 02/25/2013 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 02/26/2013 |
| Iliyotumwa Kwanza: | 02/27/2013 |
| Sasisho la Mwisho Liliwasilishwa: | 09/17/2019 |
| Sasisho la Mwisho Lilichapishwa: | 09/19/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 01/31/2013 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 05/31/2020 |
| Tarehe ya Kukamilisha Utafiti: | 05/31/2020 |
Hali au ugonjwa
Intracranial Aneurysms
Seizure
Uingiliaji / matibabu
Drug: Levetiracetam
Awamu
Awamu 4
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: Levetiracetam 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. | Drug: Levetiracetam Details covered in Arm Descriptions. |
| No Intervention: No levetiracetam No levetiracetam |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Adult (≥18 years) - Presence of intracranial aneurysm (with or without rupture) - Treating surgeon has recommended surgical repair of the aneurysm Exclusion Criteria: - History of seizures within last 10 years - History of epilepsy - History of prior stroke - Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.) - Brain tumor - Pregnant or nursing woman - Known levetiracetam allergy |
Matokeo
Hatua za Matokeo ya Msingi
1. Incidence of seizure [1 year from procedure]
