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Ketamine + Propofol for Traumatic Brain Injury (Ketamine Trial)

Phase 4

Recruiting

Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults 18-65 years of age

Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outpatient follow-up six months after intervention.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if using a combination of ketamine and propofol is safe for sedating patients with severe traumatic brain injury in the intensive care unit, compared to the standard sedation method.

Who is the study for?

This trial is for adults aged 18-65 with severe traumatic brain injury (TBI), indicated by a Glasgow Coma Scale score of 8 or less, who need intracranial pressure monitoring and are being treated in an ICU.

What is being tested?

The study compares the safety of sedation using ketamine combined with propofol versus standard care options like propofol alone or other common sedatives used in intensive care settings for patients with severe TBI.

What are the potential side effects?

Ketamine may cause side effects such as high blood pressure, increased heart rate, hallucinations, and agitation. Propofol can lead to low blood pressure, pain at the injection site, and drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have a severe brain injury and needed a device to monitor my brain.

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I am in the ICU with a device to monitor brain pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outpatient follow-up six months after intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outpatient follow-up six months after intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and outpatient follow-up six months after intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean ICP

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

Secondary study objectives

Glasgow Coma Outcome Scale extended (GOSE-TBI) scores

Incidence of cardiac arrhythmias

Incidence of post-traumatic stress disorder (PTSD) in outpatient setting

+7 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketamine with propofolExperimental Treatment1 Intervention

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

Group II: SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepamActive Control1 Intervention

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

0 / 3Eligibility criteria met