Prevention of early postoperative seizures by perampanel

JRCT ID: jRCTs031230730

Registered date:25/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patient undergoing surgery for supratentorial brain tumors
• Date of first enrollment: 25/04/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): a single-dose drip infusion of perampanel 6 mg intravenously during surgery

Outcome(s)

• Primary Outcome: Incidence of CTCAE grade 3 or higher adverse events related to study drug

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sugii Narushi
• Source(s) of Monetary Support: University of Tsukuba Hospital