Ketamine for Sedation in Severe Traumatic Brain Injury

NCT06429657 | Suspended Phase 4 FDA Drug

• 1 other identifier: C.2024.025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Traumatic Brain Injury; Intracranial Hypertension; Intracranial Hemorrhage, Hypertensive

Keywords

TBI; Severe TBI; Traumatic Brain Injury; Sedation; Ketamine

Outcome Measures

Primary Outcomes (2)

• Number of ICP elevations greater than 22 mmHg for greater than 5 minutes

  ICP elevations \> 22 mmHg for greater than 5 minutes.

  During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting

• Mean ICP

  Mean ICP

  During the maximum 5-day course of study intervention.

Secondary Outcomes (10)

• Total time spent with intracranial pressure (ICP) >22 mmHg

  During the maximum 5-day course of study intervention.

• Mean Cerebral Perfusion Pressure (CPP)

  During the maximum 5-day course of study intervention.

• Total time spent with CPP <60 mmHg

  During the maximum 5-day course of study intervention.

• Total number of events where CPP <60 mmHg for greater than 5 minutes

  During the maximum 5-day course of study intervention.

• Vasopressor dependency index (VDI)

  During the maximum 5-day course of study intervention.

Study Arms (2)

Ketamine with propofol

EXPERIMENTAL

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

Drug: Ketamine with propofol

SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam

ACTIVE COMPARATOR

Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam.

Other: Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam

Interventions

Ketamine with propofol DRUG

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

Ketamine with propofol

Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam OTHER

Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam administered according to the institutional SOC guidelines.

SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-65 years of age
• Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring
• Placement of intracranial pressure monitor
• Receiving treatment in an intensive care unit (ICU)

You may not qualify if:

• Significant cardiovascular disease with recent coronary intervention
• Pregnancy
• Prisoners
• Known allergy to ketamine or propofol

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator
• Brooke Army Medical Center: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (52)

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  BACKGROUND

• Michalczyk, Lukasz, and Lukasz Kaczmarek.

  BACKGROUND

• Chan, Kai En, et al.

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension; Intracranial Hemorrhage, Hypertensive

Interventions

Ketamine; Propofol; Fentanyl; Dexmedetomidine; Morphine; Hydromorphone; Midazolam; Lorazepam

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Benzodiazepinones

Study Officials

• Bradley Dengler, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 28, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)