drugset / Trial / NCT06741930
Pro-Epileptic Effects of IV Ketamine
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
- Results Az A, Dogan Y. Unexpected consequences: A case of ketamine-induced seizure in procedural sedation. Turk J Emerg Med. 2024 Oct 1;24(4):259-261. doi: 10.4103/tjem.tjem_67_24. eCollection 2024 Oct-Dec.
- Results Kim JH, Lee CK, Yu SH, Min BD, Chung CE, Kim DC. Ketamine-induced generalized convulsive seizure during procedural sedation. Arch Craniofac Surg. 2021 Apr;22(2):119-121. doi: 10.7181/acfs.2021.00094. Epub 2021 Apr 20.
- Results Shehata IM, Kohaf NA, ElSayed MW, Latifi K, Aboutaleb AM, Kaye AD. Ketamine: Pro or antiepileptic agent? A systematic review. Heliyon. 2024 Jan 10;10(2):e24433. doi: 10.1016/j.heliyon.2024.e24433. eCollection 2024 Jan 30.
- Results Besha A, Adamu Y, Mulugeta H, Zemedkun A, Destaw B. Evidence-based guideline on management of status epilepticus in adult intensive care unit in resource-limited settings: a review article. Ann Med Surg (Lond). 2023 Apr 17;85(6):2714-2720. doi: 10.1097/MS9.0000000000000625. eCollection 2023 Jun.
- Results Cohen SP, Bhatia A, Buvanendran A, Schwenk ES, Wasan AD, Hurley RW, Viscusi ER, Narouze S, Davis FN, Ritchie EC, Lubenow TR, Hooten WM. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):521-546. doi: 10.1097/AAP.0000000000000808.
- Results Zanos P, Moaddel R, Morris PJ, Riggs LM, Highland JN, Georgiou P, Pereira EFR, Albuquerque EX, Thomas CJ, Zarate CA Jr, Gould TD. Ketamine and Ketamine Metabolite Pharmacology: Insights into Therapeutic Mechanisms. Pharmacol Rev. 2018 Jul;70(3):621-660. doi: 10.1124/pr.117.015198.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |