Clinical TrialTraumatic Brain Injury (TBI)KetamineRecruiting

Ketamine in Severe Traumatic Brain Injury

This early Phase I interventional trial (n=10) will assess the neurophysiological effect of ketamine in patients with severe Traumatic Brain Injury (TBI).

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This pilot, non-randomised single-group study will characterise the neurophysiological response to a single dose of ketamine in critically ill patients with severe TBI monitored with intracranial pressure (ICP) and brain tissue oxygenation (PbtO2).

Primary assessments include acute changes in ICP and PbtO2 and other safety/tolerability measures; enrollment is estimated at 10 participants at Parkland Memorial Hospital.

Study Arms & Interventions

Ketamine

experimental

Single-dose ketamine in severe TBI with ICP and PbtO2 monitoring.

Interventions

  • Ketamine
    • single dose• 1 doses total

    Administration per ICU protocol; route not specified in registry text.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Severe traumatic brain injury
  • Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation (PbtO2)
  • Age greater than or equal to 18 years

Exclusion Criteria

  • Exclusion Criteria:
  • Documented allergy to ketamine
  • Sinus tachycardia with sustained heart rate >120
  • Any episode of non-sinus tachycardia
  • Documented history of schizophrenia
  • Systolic blood pressure >180 or diastolic blood pressure >120
  • Documented episode(s) of ICP elevations >25 mm Hg sustained greater than 5 minutes within 24 hours
  • Episodes of PbtO2 <15 mmHg
  • Positive pregnancy test and/or currently breastfeeding

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2024-02-01
    End: 2024-11-30
  • Compound
    Ketamine
  • Topic
    Traumatic Brain Injury (TBI)

Locations

Parkland Memorial Hospital — Dallas, Texas, United States
Parkland Memorial Hospital — Dallas, Texas, United States

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