Shuli Liang1, Ping Ding2, Shaohui Zhang3, Junchen Zhang4, Jiwu Zhang5, Yuping Wu6. 1. Neurosurgery Department, PLA General Hospital, Beijing, China; Neurosurgery Department, First Affiliated Hospital of PLA General Hospital, Beijing, China. Electronic address: liangsl_304@sina.com. 2. Neurosurgery Department, PLA General Hospital, Beijing, China; Neurosurgery Department, First Affiliated Hospital of PLA General Hospital, Beijing, China. 3. Neurosurgery Department, First Affiliated Hospital of PLA General Hospital, Beijing, China. 4. Neurosurgery Department, Affiliated Hospital of Jining Medical College, Jining, China. 5. Neurosurgery Department, Heze Xincheng Hospital, Heze, China. 6. Neurosurgery Department, Second Affiliated Hospital of Hebei Medical University, Shijiazhuang, China.
Abstract
OBJECTIVE: To study efficacy and safety of prophylactic levetiracetam (LEV) administration in adults undergoing cranioplasty. METHODS: We prospectively enrolled and randomly divided 200 adults undergoing cranioplasty into 2 groups: LEV (prophylactic LEV for 24 weeks) and control (no prophylactic antiepileptic drugs). Demographic and clinical characteristics; occurrence of postoperative seizure; changes in IQ, memory quotient, and activities of daily living scores; and postoperative side effects during hospital stay were analyzed at 2-, 24-, and 48-week follow-up visits. RESULTS: Significant differences were found between groups in both early-stage seizures in the initial 2 weeks and late-stage seizures in the 3-24 weeks after cranioplasty (P < 0.05). Postoperative seizures occurred in 17.0% in the control group and 4.1% in the LEV group 48 weeks after cranioplasty, which was found to be significant (P = 0.0020). Patients with abnormal preoperative or postoperative electroencephalography (EEG) with spikes or sharp waves presented with an increased number of postoperative seizures compared with patients with normal EEG readings at 48 weeks. Significant differences were found between patients with postoperative seizures and patients without postoperative seizures in regard to changes in IQ, memory quotient, activities of daily living, and patient satisfaction scores (P < 0.01). No significant difference was found in side effects between the 2 groups. CONCLUSIONS: Postoperative seizure is a common complication of cranioplasty, especially in patients with preoperative or postoperative abnormal EEG with spikes or sharp waves. Prophylactic LEV administration significantly reduced postcranioplasty seizures during LEV usage and had few side effects.
RCT Entities:
OBJECTIVE: To study efficacy and safety of prophylactic levetiracetam (LEV) administration in adults undergoing cranioplasty. METHODS: We prospectively enrolled and randomly divided 200 adults undergoing cranioplasty into 2 groups: LEV (prophylactic LEV for 24 weeks) and control (no prophylactic antiepileptic drugs). Demographic and clinical characteristics; occurrence of postoperative seizure; changes in IQ, memory quotient, and activities of daily living scores; and postoperative side effects during hospital stay were analyzed at 2-, 24-, and 48-week follow-up visits. RESULTS: Significant differences were found between groups in both early-stage seizures in the initial 2 weeks and late-stage seizures in the 3-24 weeks after cranioplasty (P < 0.05). Postoperative seizures occurred in 17.0% in the control group and 4.1% in the LEV group 48 weeks after cranioplasty, which was found to be significant (P = 0.0020). Patients with abnormal preoperative or postoperative electroencephalography (EEG) with spikes or sharp waves presented with an increased number of postoperative seizures compared with patients with normal EEG readings at 48 weeks. Significant differences were found between patients with postoperative seizures and patients without postoperative seizures in regard to changes in IQ, memory quotient, activities of daily living, and patient satisfaction scores (P < 0.01). No significant difference was found in side effects between the 2 groups. CONCLUSIONS:Postoperative seizure is a common complication of cranioplasty, especially in patients with preoperative or postoperative abnormal EEG with spikes or sharp waves. Prophylactic LEV administration significantly reduced postcranioplasty seizures during LEV usage and had few side effects.