Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation

Phase 4

Completed

Conditions: Intubation Complication

Interventions: Drug: Etomidate
Drug: Ketamine

Registration Number: NCT03545503

Lead Sponsor: South East Area Health Education Center, Wilmington, NC

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 428

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate	Etomidate	Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push
Ketamine	Ketamine	Ketamine will be dosed once at a standard 2 mg/kg via IV Push

Primary Outcome Measures

Name	Time	Method
Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI	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.	The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.

Secondary Outcome Measures