Recruiting
Early Phase 1

Ketamine

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06062628

Conditions

Traumatic Brain Injury

Traumatic Encephalopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Traumatic Encephalopathy

Study ID

NCT06062628

Start date

Jun 1, 2026

Status verified date

Jan, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Ketamine Hydrochloride

Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation

Primary outcome measure

  • Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor) [ Time Frame: 3 hours ]
  • Brain tissue oxygenation (measured by intracranial oxygen probe) [ Time Frame: 3 hours ]

Central Contacts and Locations

Locations

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • ketamine
  • traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-14.