Outcomes
convulsions, arrhythmia, seizure, respiratory arrest, Seizure, hypotension, SE
RECURRENCE, ARRHYTHMIA, RESPIRATORY ARREST, CARDIAC ARREST, LIVER DISEASE, ADVERSE EVENT
The primary outcome was the seizure cessation rate within 30 min of starting administration of the study drug. Seizure cessation in each patient was defined as the cessation of an apparent seizure 30 min after the administration of FPHT or LEV. Seizure cessation was not achieved when convulsions continued, convulsions reoccurred within 30 min, or a third-line treatment, described above, was introduced within 30 min.Secondary outcomes were as follows: (1) the seizure recurrence rate within 24 hours, which was confirmed by an apparent seizure or non-convulsive seizure detected by EEG; (2) the serious adverse event rate throughout the observational period potentially induced by the study drugs, such as cardiac arrest, life-threatening arrhythmia, respiratory arrest and hypotension; and (3) the intubation rate within 24 hours.Other observation items were as follows: (1) basic information on age, sex, height and body weight; (2) the type of SE; (3) seizure duration before treatment; (4) the cause of SE; (5) the modified Rankin Scale 7 days after admission; (6) the administered dose of diazepam and the time between intravenous diazepam and intravenous study drugs; (7) the administered dose of FPHT and LEV at loading and within 24 hours; (8) a previous history of liver disease; and (9) serum creatinine levels on admission.