None listed
Conditions
Brief summary
Patients with acute traumatic brain injury (TBI) requiring admission to the ICU, commonly receive sedative drugs to reduce the brain’s demand for oxygen and glucose. These patients often also require pain-relieving (analgesic) medications. Ketamine is a combined sedative and analgesic medication that is not currently used in acute TBI but has the potential to benefit this patient group for several reasons: 1. It can reduce the need for high doses of other sedatives and analgesic drugs which may accumulate or cause low blood pressure 2. It can reduce or eliminate the need for other drug infusions which are required to maintain a normal or high blood pressure during the treatment of TBI 3. It has been shown to reduce the incidence of damaging waves of brain activation that travel across the surface of the brain after severe TBI (Spreading Depolarizations). This pilot feasibility study aims to demonstrate that using Ketamine sedation is safe in acute TBI patients admitted to the ICU and will establish the methodology for a larger randomised controlled trial.
Interventions
Ketamine delivered via continuous intravenous infusion at 1mg/kg/hr of lean body mass for a maximum of 120hrs (5 days) then ceased. Ketamine is in addition to standard sedation which must include an infusion of GABA agonist medication e.g. Propofol or Mizadolam. Protocol compliance will be monitored via the electronic medical record.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Intensive care unit (ICU) admission for management of moderate to severe traumatic brain injury with abnormal CT scan, Glasgow Coma Score of 12 points or less on admission Requirement for intracranial monitoring Clinically stable and sedated with an infusion of GABA agonist medication Enrolled in the PRECISION-TBI study Expected period of ICU sedation for at least 48hrs For full active management Randomised as soon as practicable after ICU admission
Exclusion criteria
Pregnancy Documented or suspected hypersensitivity to Ketamine Known or suspected chronic kidney or liver disease History of severe coronary artery disease or evidence of acute coronary syndrome Admitted for palliative management Greater than 72hrs since time of injury has elapsed
Outcome results
None listed