Clinical trial NCT03545503: Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Official title: A Randomized Controlled Trial to Evaluate the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation Complication
Keywords: Rapid Sequence Intubation
Hemodynamics
Etomidate
Ketamine
Lead sponsor: South East Area Health Education Center, Wilmington, NC
Sponsor class: OTHER
Collaborators: name: New Hanover Regional Medical Center
First posted: 2018-06-04
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.

Detailed description: This is a randomized prospective study evaluating the hemodynamic response in adult participants greater than or equal to 18 years of age undergoing RSI in the pre-hospital or emergency department setting. Hemodynamic response is the cardiology response of the circulatory system. The investigators will compare the drugs Ketamine and Etomidate in participants having RSI. Ketamine and Etomidate are immediately available for RSI in both settings as both are currently standards of care for RSI.

Research thus far demonstrates that both Etomidate and ketamine are safe and effective for RSI. Despite the reported safety of Ketamine, Etomidate usage continues to far surpass that of ketamine. Both Etomidate and Ketamine are FDA-approved for induction of anesthesia. They are both ideal drugs for intubation due to their pharmacokinetic properties including a quick onset of less than 60 seconds, a short duration of about 10 minutes, and the minimal effect they have on the cardiovascular system. The neutral effect on the cardiovascular system is particularly important in the acute and traumatic setting when patients are often hypotensive.

However, there are some differences and disadvantages in the two medications. Due to these factors and limited data to support Ketamine as an equal or superior alternative to Etomidate, it has been difficult to clearly recommend one agent over the other for RSI.

Data will be analyzed using SPSS with a p-value of less than 0.05 being considered significant. The PI will consider a 20% decrease in systolic BP from a participant baseline as significant, and will compare the incidence of post RSI hypotension between the two groups. Several a priori subgroups will be evaluated to include patients greater than 70 years of age, trauma participants requiring RSI, and those participants whose shock index is less than 0.9 versus those whose shock index is greater than 0.9.

To maintain 80% power with a probability of 0.05, 200 participants will be needed in each arm to detect at 25% difference in SBP (baseline to post drug administration effects)

Eligibility criteria: Inclusion Criteria:

* Persons greater than 18yrs requiring rapid sequence intubation for any reason.

Exclusion Criteria:

* Pregnant patients
* Children under the age of 18
* Patients with a known hypersensitivity to etomidate or ketamine

Primary outcomes:
measure: Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI
timeFrame: The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
Study officials:
affiliation: New Hanover Regional Medical Center
name: William F Powers IV, MD
role: PRINCIPAL_INVESTIGATOR
References: