Ketamine in Severe Traumatic Brain Injury

January 12, 2026 updated by: Anna Bashmakov, University of Texas Southwestern Medical Center

Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury

Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Severe traumatic brain injury
  • Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • Documented allergy to ketamine
  • Sinus tachycardia with sustained heart rate >120
  • Any episode of non-sinus tachycardia
  • Documented history of schizophrenia
  • Systolic blood pressure > 180, diastolic blood pressure > 120
  • Documented episode(s) of ICP elevations >25 mm Hg sustained greater than 5 minutes within 24 hours
  • Similar episodes as above of PbtO2 <15 mmHg
  • Positive pregnancy test and/or is currently breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine Intervention Arm
A single dose of 0.5 mg/kg (actual body weight) of ketamine will be administered intravenously. Ketamine will be administered in addition to the patient's existing analgesia, sedation and other medicines as a part of their routine treatment.
Drug: Ketamine Hydrochloride
Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor)
Time Frame: 3 hours
Measurement of pressure within the rigid skill, with values greater than 22 mm Hg sustained proven to be injurious in patients with traumatic brain injury
3 hours
Brain tissue oxygenation (measured by intracranial oxygen probe)
Time Frame: 3 hours
Measurement of the concentration of oxygen within the brain tissue, with values less than 20 mmHg sustained proven to be injurious in patients with traumatic brain injury
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Anna Bashmakov, D.O., University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2023-0805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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