Quelling of Excitotoxicity in Acute Stroke With Ketamine
Status: | Not yet recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | July 1, 2019 |
End Date: | December 31, 2020 |
Contact: | Sudhir Aggarwal, MD, PhD |
Email: | saggarwal@dh.org |
Phone: | 2153450105 |
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.
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 1 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.
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 1 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.
Inclusion Criteria:
1. All patients who are 18 years or older, presenting or admitted to the Doylestown
Hospital with acute ischemic stroke, up to 24 hours since their last known well time
2. An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC
correlate
3. Pre-stroke modified Rankin scale of 0-2
4. Patient should be willing to participate in the study by providing a written consent
himself/herself or through a proxy.
Exclusion Criteria:
1. Eligibility to receive IV alteplase or intra-arterial thrombectomy/embolectomy
2. Longer than 24 hours since last known well time
3. Pre-stroke modified Rankin scale of 3 or above.
4. Pregnant or lactating females
5. Pre-existing psychiatric illness
6. Intracranial hemorrhage of any type at presentation
7. Seizure at onset of symptoms
8. Inability/refusal to provide consent by the patient or through a proxy
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