Quelling of Excitotoxicity in Acute Stroke With Ketamine "QUEST-KETA"

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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).

Outcomes

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

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