epilepsy
Conditions
Interventions
Experimental group :Pharmaceutical interventions
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Those who are ready for neurosurgery and are judged by the investigator to need epilepsy prevention; (2) Male or female aged 18 years and older; (3) Patients or their families are able to fully understand the voluntary participation in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who are known to be allergic or allergic to the test drug or its components, phenytoin, and other hydantoin; (2) Those who need to use sedatives during the test; (3) Intracranial lesions that cannot be or are not completely resected, such as hematoma, glioma, etc.; (4) Severe liver, kidney, heart, brain insufficiency or other serious underlying diseases; (5) Those who have a history of epilepsy in the past (one seizure before surgery is excluded); (6) Those with a Glasgow Coma Index (GCS) score of =5; (7) Pregnant and lactating women; (8) Patients who have participated in other clinical trials within one month before screening; (9) Those who are considered by the investigator to be inappropriate to be selected for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Seizures within 7 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Seizures within 14 days after operation;Evaluate the heterogeneous differences in the efficacy of Fosphenytoin sodium concentrated solution for injection preventing postoperative epileptic seizures in neurosurgery (such as age, BMI, race, gender, condition, concomitant treatment, etc.), explore its reasonable clinical positioning and therapeutic characteristics;Incidence of Seizures within 14 days after operation reduced compared with that of historical controls;Vital signs: temperature, pulse, breath, and blood pressure;Physical examination;Laboratory diagnosis:blood routine(WBCRBCHGBPLTNEUTLYM)urine routine(WBCRBCPHPROKETGLU)liver function(ALTASTTBILALP?-GGT)renal function(CrUrea/BUN);ECG;Adverse events/Adverse reactions; | — |
Countries
China
Contacts
Public ContactYou Chao
West China Hospital, Sichuan University
Outcome results
None listed