Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
NCT ID: NCT03545503
Last Updated: 2021-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
428 participants
INTERVENTIONAL
2018-01-01
2019-09-01
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Etomidate
Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push
Etomidate
Etomidate will be administered as the sedative for RSI on even days
Ketamine
Ketamine will be dosed once at a standard 2 mg/kg via IV Push
Ketamine
Ketamine will be administered as the sedative for RSI on odd days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children under the age of 18
* Patients with a known hypersensitivity to etomidate or ketamine
18 Years
ALL
No
Sponsors
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New Hanover Regional Medical Center
OTHER
South East Area Health Education Center, Wilmington, NC
OTHER
Responsible Party
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William F Powers, IV, MD
Assistant Professor of Surgery
Principal Investigators
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William F Powers IV, MD
Role: PRINCIPAL_INVESTIGATOR
New Hanover Regional Medical Center
Locations
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New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1712-4
Identifier Type: -
Identifier Source: org_study_id