Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation (Ket-RSI)
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|ClinicalTrials.gov Identifier: NCT03545503|
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intubation Complication||Drug: Etomidate Drug: Ketamine||Phase 4|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial to Evaluate the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Active Comparator: Etomidate
Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push
Etomidate will be administered as the sedative for RSI on even days
Other Name: Amidate
Active Comparator: Ketamine
Ketamine will be dosed once at a standard 2 mg/kg via IV Push
Ketamine will be administered as the sedative for RSI on odd days
Other Name: Ketalar
- Hemodynamic effect as measured by systolic blood pressure before and after RSI [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545503
|Contact: Belinda R Lissor, CCRPfirstname.lastname@example.org|
|United States, North Carolina|
|New Hanover Regional Medical Center||Recruiting|
|Wilmington, North Carolina, United States, 28401|
|Contact: Belinda R Lissor, AAS, CCRP 910-667-9281 Belinda.Lissor@seahec.net|
|Principal Investigator:||William F Powers IV, MD||New Hanover Regional Medical Center|