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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
Sponsor:
Collaborator:
New Hanover Regional Medical Center
Information provided by (Responsible Party):
William F Powers, IV, MD, 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.

Condition or disease Intervention/treatment Phase
Intubation Complication Drug: Etomidate Drug: Ketamine Phase 4

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Etomidate
Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push
Drug: Etomidate
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
Drug: Ketamine
Ketamine will be administered as the sedative for RSI on odd days
Other Name: Ketalar




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Belinda R Lissor, CCRP 910-667-9281 belinda.lissor@seahec.net

Locations
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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   
Sponsors and Collaborators
South East Area Health Education Center, Wilmington, NC
New Hanover Regional Medical Center
Investigators
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Principal Investigator: William F Powers IV, MD New Hanover Regional Medical Center

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Responsible Party: William F Powers, IV, MD, Assistant Professor of Surgery, South East Area Health Education Center, Wilmington, NC
ClinicalTrials.gov Identifier: NCT03545503     History of Changes
Other Study ID Numbers: 1712-4
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by William F Powers, IV, MD, South East Area Health Education Center, Wilmington, NC:
Rapid Sequence Intubation
Hemodynamics
Etomidate
Ketamine
Additional relevant MeSH terms:
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Ketamine
Etomidate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives