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Phase 4 N=143 Randomized Treatment

Ketamine Versus Etomidate for Rapid Sequence Intubation

Airway Control · Anesthesia · Intubation · Complication

Enrolled (actual)
143
Serious AEs
0.8%
Results posted
May 2019
Primary outcome: Primary: SOFA Score — 6.5; 7 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ketamine (Drug); Etomidate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hennepin Healthcare Research Institute
Primary completion
Oct 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
SOFA Score
6.5; 7
SECONDARY
Mortality in Sepsis and Septic Shock
1; 4
SECONDARY
Number of Patients With First-pass Success
59; 60
SECONDARY
Doses of Post-intubation Sedation
1; 1
SECONDARY
Number of Patients With Post-intubation Hypoxemia
8; 13; 1; 5
SECONDARY
Number of Patients With Hypotension
24; 30; 16; 17
SECONDARY
Peak and Plateau Pressure
25; 26; 16; 17
SECONDARY
Mortality
8; 15

Summary

The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).

Eligibility Criteria

Inclusion Criteria

  • 18 years of age
  • Undergoing rapid sequence intubation (RSI) in the Emergency Department

Exclusion Criteria

  • Known contraindication to ketamine or etomidate
  • Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
  • Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
  • Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
  • Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
  • Prisoner
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01823328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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