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  • A systematic review of peri-operative seizure prophylaxis during brain tumor resection: the case for a multi-center randomized clinical trial

    Final Number:
    4158

    Authors:
    Vyshak Chandra MS, BSc.; Andrew Karl Rock MHS MS; Charles Frederick Opalak MpH, MD; Joel Michael Stary MD; Adam Sima; Matthew Thomas Carr BS; Rafael A. Vega MD, PhD; William C. Broaddus MD

    Study Design:
    Other

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2017 Annual Meeting - Late Breaking Science

    Introduction: The majority of neurosurgeons administer anti-epileptic drugs (AED) prophylactically for supratentorial tumor resection. There is not clear evidence in the literature to support this practice. The putative prophylactic benefit of perioperative seizure prophylaxis must be weighed against the risks of adverse effects and drug interactions in patients without a history of seizures. Consequently, the authors conducted a systematic review of prospective randomized controlled trials (RCT) that have evaluated the efficacy of perioperative seizure prophylaxis during brain tumor resection among patients without a history of seizures.

    Methods: Five databases (Pubmed/MEDLINE, the Cochrane Central Register of Controlled Trials, CINAHL/Academic Search Complete, Web of Science, and ScienceDirect) were searched for RCTs investigating perioperative seizure prophylaxis in brain tumor resection published before May 2017. Of the 496 unique research articles identified, there were four studies selected for inclusion in this review.

    Results: This systematic review identified four RCTs that met inclusion criteria. The weighted average seizure incidence was 10.65% within the untreated groups. No significant difference was observed in the seizure rates among patients who received seizure prophylaxis when compared to those who did not. Using the observed seizure incidence, it was estimated that a total of 1,236 patients would be required for a RCT to demonstrate non-inferiority based on a Farrington-Manning non-inferiority test performed at the 0.05 level using a non-inferiority difference of 0.05%. None of the current RCTs to date have met this sample size, which highlights the need for a multi-center RCT.

    Conclusions: Based on our systematic review of major RCTs, there is not a significant reduction in the incidence of seizures among those who receive prophylactic AEDs following brain tumor resection when compared to controls. A large multi-center RCT is required to assess whether perioperative seizure prophylaxis provides benefit for patients undergoing brain tumor resection.

    Patient Care: This study highlights the major findings from a systematic review of randomized clinical trials (RCT) investigating the efficacy for prophylactic anti-epileptic drug (AED) seizure prophylaxis following brain tumor resection among patients without a history of seizures. Our results recognize an ongoing lack of quality evidence supporting or refuting the use of prophylactic AEDs following brain tumor resection. We propose the need for a multi-center non-inferiority RCT on this topic to further weigh the risks and benefits of prophylactic AED use.

    Learning Objectives: At the conclusion of this session, participants should be able to: 1) describe the current state of the literature related to randomized clinical trials evaluating the efficacy of prophylactic seizure prophylaxis following brain tumor resection among patients without a prior history of seizures; and 2) understand the sample size necessary to demonstrate non-inferiority from a multi-center RCT on this topic.

    References: 1) De Santis A, Villani R, Sinisi M, Stocchetti N, Perucca E. Add-on phenytoin fails to prevent early seizures after surgery for supratentorial brain tumors: A randomized controlled study. Epilepsia (Series 4). 2002;43(2):175-182. doi: 10.1046/j.1528-1157.2002.24801.x. 2) Franceschetti S, Binelli S, Casazza M, et al. Influence of surgery and antiepileptic drugs on seizures symptomatic of cerebral tumours. Acta Neurochir. 1990;103(1):47-51. doi: 10.1007/BF01420191. 3) Ture H, Sayin M, Karlikaya G, Bingol CA, Aykac B, Ture U. The analgesic effect of gabapentin as a prophylactic anticonvulsant drug on postcraniotomy pain: A prospective randomized study. Anesth Analg. 2009;109(5):1625-1631. doi: 10.1213/ane.0b013e3181b0f18b. 4) Wu AS, Trinh VT, Suki D, et al. A prospective randomized trial of perioperative seizure prophylaxis in patients with intraparenchymal brain tumors. J Neurosurg. 2013;118(4):873-883. doi: 10.3171/2012.12.JNS111970.

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