Brain Injury and Ketamine: a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in acute brain injury patients.

Conditions

Traumatic brain injury

Brief summary

Reduction in cumulative daily TIL score., The number of high intracranial pressure episodes defined as an ICP >22 mmHg for >25 minutes

Detailed description

The average intracranial pressure (mmHg) per 24h, Total duration of the first episode of sedative treatment (hours), Total duration of the first episode of mechanical ventilation, Total dose of propofol in mg per 24 hours, Total dose of midazolam in mg per 24 hours, Length of stay in the Intensive Care Unit (ICU), Length of stay in the hospital (days), Average daily Richmond agitation and sedation score (RASS) (addendum 2) per hour, Delirium-free days, defined with the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method-ICU (CAM-ICU) every 8 hours (ICDSC), Extended Glasgow Outcome Score (GOSE) at 6 months after the onset of brain injury, The incidence of barbiturate coma, Incidence of decompressive craniectomy, Incidence of Propofol-Related Infusion Syndrome (PRIS)

Related papers

No related papers found yet.

Interventions

DRUGKetalar 50 mg/ml solution injectable

DRUG0

DRUG9% NaCl

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Reduction in cumulative daily TIL score., The number of high intracranial pressure episodes defined as an ICP >22 mmHg for >25 minutes	—

Secondary

Measure	Time frame
The average intracranial pressure (mmHg) per 24h, Total duration of the first episode of sedative treatment (hours), Total duration of the first episode of mechanical ventilation, Total dose of propofol in mg per 24 hours, Total dose of midazolam in mg per 24 hours, Length of stay in the Intensive Care Unit (ICU), Length of stay in the hospital (days), Average daily Richmond agitation and sedation score (RASS) (addendum 2) per hour, Delirium-free days, defined with the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method-ICU (CAM-ICU) every 8 hours (ICDSC), Extended Glasgow Outcome Score (GOSE) at 6 months after the onset of brain injury, The incidence of barbiturate coma, Incidence of decompressive craniectomy, Incidence of Propofol-Related Infusion Syndrome (PRIS)	—

Measure

Time frame

The average intracranial pressure (mmHg) per 24h, Total duration of the first episode of sedative treatment (hours), Total duration of the first episode of mechanical ventilation, Total dose of propofol in mg per 24 hours, Total dose of midazolam in mg per 24 hours, Length of stay in the Intensive Care Unit (ICU), Length of stay in the hospital (days), Average daily Richmond agitation and sedation score (RASS) (addendum 2) per hour, Delirium-free days, defined with the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method-ICU (CAM-ICU) every 8 hours (ICDSC), Extended Glasgow Outcome Score (GOSE) at 6 months after the onset of brain injury, The incidence of barbiturate coma, Incidence of decompressive craniectomy, Incidence of Propofol-Related Infusion Syndrome (PRIS)

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Countries

Belgium

Outcome results

None listed