RECRUITING

Ketamine in Severe Traumatic Brain Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury

Quick Facts

Study Start:2024-03-18
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06062628

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Severe traumatic brain injury
  2. * Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation
  3. * Age greater than or equal to 18 years
  1. * Documented allergy to ketamine
  2. * Sinus tachycardia with sustained heart rate \>120
  3. * Any episode of non-sinus tachycardia
  4. * Documented history of schizophrenia
  5. * Systolic blood pressure \> 180, diastolic blood pressure \> 120
  6. * Documented episode(s) of ICP elevations \>25 mm Hg sustained greater than 5 minutes within 24 hours
  7. * Similar episodes as above of PbtO2 \<15 mmHg
  8. * Positive pregnancy test and/or is currently breast-feeding

Contacts and Locations

Principal Investigator

Anna Bashmakov, D.O.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

Parkland Memorial Hospital
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Anna Bashmakov, D.O., PRINCIPAL_INVESTIGATOR, UT 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 Registration Dates

Study Start Date2024-03-18
Study Completion Date2026-11

Study Record Updates

Study Start Date2024-03-18
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • ketamine
  • traumatic brain injury

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • Traumatic Encephalopathy