Clinical trial

Ketamine for Sedation in Severe Traumatic Brain Injury

Name

C.2024.025

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2027-01-01

Trial end

2027-06-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

Ketamine with propofol

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

Arms:

Ketamine with propofol

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

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

Arms:

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

Size

Primary endpoint

Number of ICP elevations greater than 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

During the maximum 5-day course of study intervention.

Eligibility criteria

Inclusion Criteria: * 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) Exclusion Criteria: * Significant cardiovascular disease with recent coronary intervention * Pregnancy * Prisoners * Known allergy to ketamine or propofol

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-05-28

1 organization

1 product

4 indications

Organization

Henry M. Jackson Foundation for the Advancement of Military Medicine

Product

Ketamine with Propofol

Indication

Severe Traumatic Brain Injury

Indication

Idiopathic Intracranial Hypertension

Indication

Intracranial Hemorrhage

Indication

Hypertension