Intracranial Hypertension Clinical Trial
Official title:
Ketamine for Sedation in Severe Traumatic Brain Injury
This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.
Patients meeting eligibility criteria and consent having been obtained by LAR will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm. Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine, for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes (coughing etc.). In the control arm, patients will receive their institutional analgosedation protocol. The sedation protocols will be continued until removal of intracranial pressure monitoring. This study will take place during the participant's hospital care. The clinical team will administer treatment using standard practices, including all safety precautions available. Side effects will be monitored closely and may decide to discontinue the subject's participation in the study should the subject's health or safety are at risk. The research team will performed one outpatient follow-up after study intervention ends. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06367868 -
Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring
|
N/A | |
Completed |
NCT04488874 -
Sodium Lactate and Brain Relaxation (LSD)
|
Phase 3 | |
Not yet recruiting |
NCT04211064 -
Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter
|
N/A | |
Completed |
NCT00571623 -
Automated Chest Physiotherapy to Improve Outcomes in Neuro
|
N/A | |
Recruiting |
NCT00437814 -
Effect of Ketamine (Ketalar) on Intracranial Pressure
|
N/A | |
Recruiting |
NCT03212976 -
Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure
|
N/A | |
Withdrawn |
NCT02558309 -
Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
|
N/A | |
Terminated |
NCT00795587 -
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
|
Phase 4 | |
Completed |
NCT00447018 -
Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
|
Phase 4 | |
Not yet recruiting |
NCT05593380 -
The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH
|
N/A | |
Completed |
NCT03364634 -
Intracranial Pressure After Decompressive Craniectomy
|
N/A | |
Unknown status |
NCT02773901 -
Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
|
N/A | |
Terminated |
NCT01973764 -
Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System
|
N/A | |
Terminated |
NCT00319345 -
Sodium-Lactate and Traumatic Brain Injury
|
Phase 2/Phase 3 | |
Recruiting |
NCT04459806 -
Intracranial PrEssure Time dOse (ImPETO)
|
||
Completed |
NCT00239525 -
3-D Transcranial Ultrasound Analysis Study
|
N/A | |
Completed |
NCT05946200 -
Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia
|
N/A | |
Completed |
NCT03957837 -
Optical Nerve Sheath Changes During Head Down Laparoscopy
|
||
Not yet recruiting |
NCT05818371 -
Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting
|
N/A | |
Completed |
NCT04429477 -
Cerebral Compliance Impairment in COVID-19
|