Adult patient undergoing brain tumor resection with surgical manipulation of the cerebrum brain tumor
Conditions
Interventions
a single-dose drip infusion of perampanel 6 mg intravenously during surgery under general anesthesia
Sponsors
Sugii Narushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients scheduled for tumor resection surgery (including biopsy) under general anesthesia for suspected brain tumor 2.Patients whose surgical procedure involves manipulation of the cerebrum 3.Patients planned to receive antiseizure medications for the prevention of early postoperative seizures 4.Patients aged 18 years or older at the time of consent, regardless of gender 5.Patients who have received sufficient explanation about the study, have a thorough understanding, and have provided written informed consent either personally or through a legally authorized representative
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to any component of the study drug 2. Patients who will continue intubation or receive continuous sedation postoperatively 3. Patients who need to resume antiseizure medications other than study drug within 7 days after surgery 4. Patients with complications of systemic diseases that may interfere with the safe performance of general anesthesia or surgery, or patients with severe conditions 5. Patients with severe liver diseases or liver enzyme abnormalities [AST (GOT) or ALT (GPT) > 200 U/L] 6. Pregnant or lactating women 7. Patients who have received other study or investigational drugs for the prevention of epileptic or convulsive seizures within a month of the scheduled administration of the study drug 8. patients deemed ineligible as subjects by the principal investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of early seizures within 7 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Background factors and timing, type, and incidence of early seizures within 7 days after surgery Occurrence of CTCAE grade 3 or higher study drug-related adverse events Hematologic toxicity on postoperative day 7 PER blood levels on days 1 and 7 Anesthesia awakening time Presence and content of medications for restlessness Factors affecting PER blood levels | — |
Contacts
Public ContactNarushi Sugii
University of Tsukuba Hospital
Outcome results
None listed