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

Intubation Complication Clinical Trial

— Ket-RSI  

Official title:

A Randomized Controlled Trial to Evaluate the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545503
• Other study ID #: 1712-4
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2021
• Source: South East Area Health Education Center, Wilmington, NC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Drug:
• Etomidate
Etomidate will be administered as the sedative for RSI on even days
• Ketamine
Ketamine will be administered as the sedative for RSI on odd days

Locations

Country	Name	City	State
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
South East Area Health Education Center, Wilmington, NC	New Hanover Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI	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.	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.