Clinical TrialNeurological InjuryKetamineKetamineCompleted

Spreading Depolarization and Ketamine Suppression

Randomized, multiple-crossover ICU study (n=10) evaluating whether continuous ketamine infusion (basal ~0.1 mg/min, titrated) suppresses cortical spreading depolarizations compared with other sedation regimens.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Hypothesis: NMDA antagonist ketamine suppresses cortical spreading depolarizations (CSD). This prospective randomized multiple crossover pilot compares ketamine versus other sedatives in 6-hour alternating blocks in patients with severe traumatic brain injury or aneurysmal subarachnoid haemorrhage undergoing craniotomy and invasive cortical monitoring.

Continuous subdural electrode (1x6 strip) recordings capture CSD occurrence while physiological data (vitals, arterial waveforms, labs, video EEG) are collected; ketamine given as continuous infusion (minimal basal 0.1 mg/min, titrated) and compared to standard sedatives with outcomes focused on CSD frequency and related physiological markers.

Study Arms & Interventions

Ketamine first

experimental

Randomized to receive ketamine as the first post-operative sedative, then cross-over every 6 hours to other sedation.

Interventions

  • Ketamine6 mg/hr
    via IV• continuous infusion

    Basal minimal infusion 0.1 mg/min (≈6 mg/hr); titrated to Riker SAS target; single 6-hour blocks alternated.

Other sedation first

experimental

Randomized to receive non-ketamine sedation (typically propofol) first, then cross-over every 6 hours to ketamine.

Interventions

  • Compound
    via IV• continuous infusion

    Other sedation (typically propofol, versed, or dexmedetomidine) titrated per ICU standard; no fixed minimal infusion required.

  • Ketamine6 mg/hr
    via IV• continuous infusion

    Ketamine used in alternating 6-hour blocks; basal minimal infusion 0.1 mg/min (≈6 mg/hr) during ketamine intervals.

Participants

Ages
18 – 90
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • GCS <8
  • SAH or severe traumatic brain injury requiring craniotomy
  • Consent obtainable (via legal representative)
  • Ictus (bleed or injury) within 48 hours of enrollment
  • Clinically appropriate for multimodality monitoring

Exclusion Criteria

  • Exclusion Criteria:
  • Anticipated survival <48 hours
  • No craniotomy
  • Infratentorial craniotomy only
  • Unable to obtain consent
  • Absence of clinically used multimodality monitoring
  • Prisoners
  • Pregnant

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment10 participants
  • Timeline
    Start: 2015-01-07
    End: 2017-01-05
  • Compounds
    KetamineKetamine
  • Topic
    Neurological Injury

Locations

University of New Mexico — Albuquerque, New Mexico, United States

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