drugset / Trial / NCT06741930

Pro-Epileptic Effects of IV Ketamine

NCT06741930 ↗

Phase 4 Completed 300 enrolled Haseki Training and Research Hospital
RandomizedCrossoverDouble-blindScreening

Summary

The investigators evaluated the safety and potential pro-epileptic effects of intravenous (IV) ketamine during procedural sedation in comparison with IV midazolam and IV propofol. Specifically, the study hypothesizes that IV ketamine, at doses used for procedural sedation, exhibits pro-convulsive properties, lowers the epileptic seizure threshold, and may induce interictal epileptiform discharges and/or seizures. Additionally, the investigators assessed the effects of these sedative agents on electroencephalographic (EEG) activity during procedural sedation.

Timeline

Start
2024-12-01
Primary completion
2025-08-30
Completion
2025-08-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 0.5 mg/kg Intravenous
Comparator Ketamine Small molecule 1 mg/kg Intravenous
Comparator Midazolam Small molecule 0.15 mg/kg Intravenous
Comparator Midazolam Small molecule 0.4 mg/kg Intravenous
Comparator Propofol Small molecule 0.5 mg/kg Intravenous
Comparator Propofol Small molecule 1 mg/kg Intravenous

Indications