The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.
After obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive Ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 40 mg/h for a period of 48 hours. The infusion will start at a rate of 10 mg/h, and then gradually tapered up during the first 3 hours by 10 mg an hour. Similarly, the infusion rate will be gradually tapered down at a rate of 10 mg/h during the last 3 hours of infusion. The patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. In order to prevent the psychogenic adverse effects associated with Ketamine, the patients will be administered Midazolam at a dose of 2 mg IV every 4 hours. Midazolam will also be administered at the same rate to the patients randomized to the placebo arm. Blood Ketamine levels will be measured before starting the treatment, and daily while the infusion is on. While receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed.
- Normal Saline Drug
Intervention Desc: IV infusion ARM 1: Kind: Experimental Label: Placebo Description: Will receive Normal saline infusion and Midazolam (Versed).
- Ketamine Drug
Intervention Desc: IV infusion ARM 1: Kind: Experimental Label: Study Drug Description: Will receive Ketamine infusion, and Midazolam (Versed).
- Midazolam injection Drug
Other Names: Versed Intervention Desc: Injection ARM 1: Kind: Experimental Label: Study Drug Description: Will receive Ketamine infusion, and Midazolam (Versed). ARM 2: Kind: Experimental Label: Placebo Description: Will receive Normal saline infusion and Midazolam (Versed).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.||On day 1 and at 90 days|
|Secondary||Barthel's index||On day 1, and at 90 days|
|Secondary||NIH stroke scale score||On day 1, day 4 or discharge whichever is earlier, and at 90 days|
|Secondary||Depression score using the PHQ9 questionnaire||On day 1, and day 4 or discharge whichever is earlier.|
|Secondary||Infarct volumes||On day 1, and day 4 or discharge whichever is earlier|
|Secondary||All cause mortality||90 days|
|Secondary||Stroke-related mortality||90 days|
|Secondary||Symptomatic intracranial hemorrhage||Day 4 or discharge whichever is earlier|
|Secondary||Deterioration in neurologic status||Up to day 4 or discharge whichever is earlier|
- Doylestown Health Lead