Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/6/2018 |
| Start Date: | January 1, 2018 |
| End Date: | January 2019 |
| Contact: | Belinda R Lissor, CCRP |
| Email: | belinda.lissor@seahec.net |
| Phone: | 910-667-9281 |
A Randomized Controlled Trial to Evaluate the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
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.
during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.
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)
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)
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
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