Ketamine + Etomidate for Post-Traumatic Stress Disorder

(RSI-LTO Trial)

Enrolling by invitation at 5 trial locations
JD
MW
Overseen ByMatthew W Semler, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different drugs, ketamine and etomidate, used during emergency intubation, might affect long-term PTSD symptoms in patients. PTSD (post-traumatic stress disorder) can occur after a person experiences a traumatic event, such as hospital intubation. The researchers aim to determine if ketamine use during intubation could reduce PTSD symptoms by blocking the pathways that create traumatic memories. Eligible participants previously took part in the RSI trial and should have been able to speak or follow commands before intubation. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using ketamine for emergency breathing tube placement does not increase the risk of death within 28 days, suggesting it is generally safe for patients. However, some studies have found that ketamine can sometimes cause very low blood pressure.

In contrast, etomidate, another drug used for this procedure, has been linked to a higher risk of in-hospital death compared to ketamine, which might concern some patients. Both drugs can cause low blood pressure, heart issues, or even death in very sick patients.

These findings, based on past research, help clarify the safety of ketamine and etomidate. Patients should discuss any concerns with their healthcare provider before joining a trial.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how ketamine and etomidate, two different sedatives, might affect long-term outcomes after emergency tracheal intubation. Unlike other sedatives typically used in this setting, ketamine has a unique mechanism of action—it works by blocking NMDA receptors in the brain, which can provide pain relief and a dissociative state. Etomidate, on the other hand, is known for its hemodynamic stability, meaning it maintains blood pressure without major fluctuations. By comparing these two drugs, researchers hope to discover which might lead to better outcomes for patients needing rapid sequence intubation in emergencies.

What evidence suggests that this trial's treatments could be effective for preventing PTSD symptoms?

This trial will compare ketamine and etomidate as sedatives for anesthesia induction during emergency tracheal intubation. Research has shown that ketamine can reduce PTSD symptoms in individuals with long-term PTSD for up to two weeks by blocking certain brain pathways that create traumatic memories. Both ketamine and etomidate effectively induce sleep for medical procedures, but ketamine might also help prevent PTSD. Conversely, etomidate is less likely to cause low blood pressure after procedures, which can be crucial for some patients. Both drugs offer benefits, but ketamine might provide special advantages for those at risk of PTSD after serious illness.13567

Are You a Good Fit for This Trial?

Inclusion Criteria

You are already taking part in the RSI trial with the identification number NCT05277896.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous ketamine or etomidate as the sedative for induction of anesthesia during emergency tracheal intubation

Immediate

Follow-up

Participants are monitored for PTSD symptoms, quality of life, cognition, and other outcomes

12 months

Long-term outcomes assessment

Assessment of long-term outcomes such as PTSD symptoms, quality of life, and cognitive function

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Etomidate
  • Ketamine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Comparator: Ketamine GroupExperimental Treatment1 Intervention
Group II: Comparator: Etomidate GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

Etomidate Compared to Ketamine for Induction during ...

The use of etomidate for induction during RSI is associated with a decreased risk of post-induction hypotension as compared to the use of ketamine.

Protocol and Statistical Analysis Plan for a Multicenter ...

The trial compares ketamine vs etomidate for induction of anesthesia among 2,364 critically ill adults undergoing emergency tracheal intubation. The primary ...

Clinical outcomes after a single induction dose of ...

In conclusion, there were no differences in early and late survival rates between etomidate and ketamine. However, etomidate was associated with ...

Ketamine versus etomidate as an induction agent for tracheal ...

This meta-analysis showed a moderate probability that induction with ketamine is associated with a reduced risk of mortality.

Randomized Trial of Sedative Choice for Intubation

Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical ...

An Expiration Date for Etomidate? - PMC

Overall, pooled data in several meta-analyses point to the potential for increased mortality when etomidate is used to facilitate endotracheal ...

Evaluation of Etomidate Use and Association with Mortality ...

Use of etomidate on the day of IMV initiation is common and associated with a higher odds of hospital mortality than use of ketamine.