Patient undergoing surgery for supratentorial brain tumors supratentorial brain tumor, early postoperative seizure
Conditions
Interventions
a single-dose drip infusion of perampanel 6 mg intravenously during surgery
Sponsors
Sugii Narushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) Patients scheduled for surgery under general anesthesia for suspected supratentorial brain tumors (ii) Patients scheduled to receive antiseizure medications for the prevention of early postoperative seizures (iii) Patients who are at least 18 years of age on the date of consent, regardless of gender (iv) Patients who have received a full explanation of the study, fully understand it, and have obtained free and voluntary written consent from the patient or a surrogate
Exclusion criteria
Exclusion criteria: (i) Patients with a history of hypersensitivity to any component of the study drug (ii) Patients who will continue intubation or receive continuous sedation postoperatively (iii) Patients who need to resume antiseizure medications other than perampanel within 7 days after surgery (iv) Patients with complications of systemic diseases that may interfere with the safe performance of general anesthesia or surgery, or patients with severe conditions (v) Patients with severe cardiovascular diseases (myocardial infarction, unstable angina, valvular disease, heart failure, etc.) that require special attention for perioperative management (vi) Patients with severe liver diseases or liver enzyme abnormalities [AST (GOT) or ALT (GPT) >130 U/L] (vii) Positive for HBs antigen, HCV antibody, or HIV antibody (viii) Pregnant or lactating women (ix) Patients who have received other study or investigational drugs for the prevention of epileptic or convulsive seizures within 3 months of the scheduled administration of the study drug (x) patients deemed ineligible as subjects by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CTCAE grade 3 or higher adverse events related to study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence, timing, and type of early postoperative seizures number and amount of benzodiazepines used for seizure cessation hematologic toxicity on Days 1 and 7 blood concentration of perampanel factors affecting perampanel blood concentration anesthetic awakening time presence and content of medication for restlessness falls | — |
Contacts
Public ContactNarushi Sugii
University of Tsukuba Hospital
Outcome results
None listed