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A Systematic Review of Perioperative Seizure Prophylaxis During Brain Tumor Resection: the Case for a Multicenter Randomized Clinical Trial

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A Systematic Review of Perioperative Seizure Prophylaxis During Brain Tumor Resection: the Case for a Multicenter Randomized Clinical Trial NEUROSURGICAL FOCUS Neurosurg Focus 43 (5):E18, 2017 A systematic review of perioperative seizure prophylaxis during brain tumor resection: the case for a multicenter randomized clinical trial Vyshak Chandra, MS,1 Andrew K. Rock, MHS, MS,1 Charles Opalak, MD, MPH,1 Joel M. Stary, MD, PhD,1 Adam P. Sima, PhD,2 Matthew Carr, BS,1 Rafael A. Vega, MD, PhD,1 and William C. Broaddus, MD, PhD1 1Department of Neurosurgery, Virginia Commonwealth University Health System, Medical College of Virginia; and 2Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia OBJECTIVE The majority of neurosurgeons administer antiepileptic drugs (AEDs) prophylactically for supratentorial tumor resection without clear evidence to support this practice. The putative benefit of perioperative seizure prophylaxis must be weighed against the risks of adverse effects and drug interactions in patients without a history of seizures. Con- sequently, the authors conducted a systematic review of prospective randomized controlled trials (RCTs) that have evalu- ated the efficacy of perioperative seizure prophylaxis among patients without a history of seizures. METHODS Five databases (PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, CINAHL/Academic Search Complete, Web of Science, and ScienceDirect) were searched for RCTs published before May 2017 and investi- gating perioperative seizure prophylaxis in brain tumor resection. Of the 496 unique research articles identified, 4 were selected for inclusion in this review. RESULTS This systematic review revealed a weighted average seizure rate of 10.65% for the control groups. There was no significant difference in seizure rates among the groups that received seizure prophylaxis and those that did not. Further, this expected incidence of new-onset postoperative seizures would require a total of 1258 patients to enroll in a RCT, as determined by a Farrington-Manning noninferiority test performed at the 0.05 level using a noninferiority differ- ence of 5%. CONCLUSIONS According to a systematic review of major RCTs, the administration of prophylactic AEDs after brain tumor resection shows no significant reduction in the incidence of seizures compared with that in controls. A large mul- ticenter randomized clinical trial would be required to assess whether perioperative seizure prophylaxis provides benefit for patients undergoing brain tumor resection. https://thejns.org/doi/abs/10.3171/2017.8.FOCUS17442 KEY WORDS brain neoplasms; neurosurgery; seizures; anticonvulsants; prevention and control; systematic review EIZURES are debilitating and burdensome for the tice was first studied in the 1980s, with investigators in a health care system. Patients with seizures have high- double-blind trial concluding that preoperative phenytoin er medical expenses, lower employment rates, and administration decreased seizure rates by 50%;20 however, barriersS to social participation.11 Seizures lead to longer the study included craniotomies for a variety of patholo- hospital stays and increased health care costs. The risk of gies, and there was no significant difference in seizure new-onset seizure for a patient with a brain tumor is re- rates between the AED-treated and untreated supratento- ported to be 20%–90%.7,12,20 Postcraniotomy seizure rates rial tumor resection groups. for patients with no prior history of seizure range from A 2015 survey of surgeons revealed that more than 63% 7% to 18%.4,5 Antiepileptic drugs (AEDs) have been used of them administer seizure prophylaxis after tumor resec- to decrease the rate of postoperative seizures. This prac- tion in patients without a history of seizures.3 Eighty-five ABBREVIATIONS AED = antiepileptic drug; RCT = randomized controlled trial. SUBMITTED July 1, 2017. ACCEPTED August 21, 2017. INCLUDE WHEN CITING DOI: 10.3171/2017.8.FOCUS17442. ©AANS, 2017 Neurosurg Focus Volume 43 • November 2017 1 Unauthenticated | Downloaded 10/01/21 09:47 PM UTC V. Chandra et al. percent of the surgeons who practice prophylaxis reported of intervention, follow-up interval, outcome definition, sei- that they use the antiepileptic levetiracetam. The dura- zure incidence, risk estimate, and conclusions. The risk of tion of prophylaxis varied from 1 week to more than 6 bias (low, high, uncertain) of included trials was assessed weeks. This suggests that a significant minority of tumor using the Cochrane Handbook for Systematic Reviews surgeons do not endorse the perioperative use of AEDs in of Interventions10 and the following 6 domains: random seizure-naïve patients. This survey also revealed that 82% sequence generation, allocation concealment, blinding, of the respondents would guide their future practice in this incomplete outcome data, selective reporting, and other area based on the results of a well-designed randomized bias. The weighted average seizure rate of untreated con- controlled trial (RCT). trols was calculated based on reported values from the in- There is no Class I evidence to support the widespread cluded studies. Power analyses were conducted using the practice of administering prophylactic AEDs in patients weighted average seizure rate to estimate the number of undergoing tumor resection. Further, pharmaceuticals are patients required to demonstrate noninferiority within an not benign. Levetiracetam can cause behavioral problems RCT. All power analyses were based on the Farrington- (anger, apathy, irritability, neurosis), headache, drowsi- Manning noninferiority test performed at the 0.05 level ness, suicidal ideation, increased blood pressure, and gas- using a noninferiority difference of 5%. trointestinal disturbances. Phenytoin has a larger set of side effects, such as atrial conduction depression, arrhyth- Results mias, cerebral atrophy, cerebral dysfunction, peripheral Study Selection neuropathy, dermatological issues, and various immu- nological issues. The total direct cost of a 7-day seizure A total of 496 unique articles were identified through prophylaxis with intravenous levetiracetam is $8784.63 the database searches and underwent title, abstract, and and with intravenous phenytoin $8743.78. The cost-ef- full-text review (Fig. 1). After screening by title, there fectiveness ratio per successful seizure prophylaxis regi- were 84 articles that underwent abstract review. Sixty- men (SSPR) was shown to be $10,044.91 for intravenous eight articles were subsequently excluded, and 16 articles levetiracetam, compared with $11,525.63 for intravenous were considered eligible for full-text review. Following phenytoin.12 the full-text review, 13 articles were excluded. Reasons Given that the perioperative administration of AEDs is for exclusion comprised a lack of perioperative seizure outcomes,15,16 a heterogeneous sample of neurosurgery pa- one of the most common practices encountered in neuro- 9 19,23 logical intensive care patients, we conducted a systematic tients, non-English language, absent assessment of sei- zure prophylaxis for brain tumor resection,7,22,28 and study review of relevant studies of perioperative seizure prophy- 13,14,21,24,25 laxis in patients undergoing tumor resection. Additionally, design other than RCT. One additional study was we provide an outline of the trial that would be necessary identified through a review of the reference lists. A total to provide Class I evidence. This is both a knowledge up- of 4 studies met inclusion criteria and were considered in date and a blueprint for moving forward. this systematic review (Table 1). Of these trials, one com- pared prophylactic phenobarbital or phenytoin to no in- tervention,8 one compared prophylactic phenytoin to no Methods intervention,27 one compared prophylactic gabapentin to Literature Search and Inclusion Criteria phenytoin use,26 and one evaluated the addition of prophy- This systematic review was conducted according to the lactic phenytoin to current AED therapy.2 Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols (PRISMA-P) guidelines.18 Assessment of Risk of Bias for the Included Studies Five databases were searched between May 10 and May Details from the assessment of risk of bias for included 13, 2017. The databases included PubMed/MEDLINE, Co- studies are presented in Fig. 2. Despite claims of being chrane Central Register of Controlled Trials (CENTRAL), RCTs, only 1 study reported methodology in support of CINAHL/Academic Search Complete, Web of Science, random sequence generation when allocating participants and ScienceDirect. Searches used combinations of specific to AED and control groups. Although 2 of the studies terms related to neurosurgery, brain neoplasm, anticon- blinded researchers for outcome assessment, none of the vulsants, and prophylaxis (details of search strategies are studies had allocation concealment or blinded participants provided in the Appendix). Only original peer-reviewed and personnel to allocated interventions. One study had randomized clinical trials in humans whose results were incomplete data for outcomes because the trial was termi- published in the English language were considered for in- nated after interim futility analysis had demonstrated that clusion. In addition, the references of previous systematic the power would be too low to show superiority between reviews, meta-analyses, and selected studies were evalu- the AED and control groups. ated for the inclusion of additional studies. Seizure Outcomes Data Extraction and Outcome Measures Four clinical trials assessed perioperative AED
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