Completed

Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation

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What is being tested

Ketamine

+ Etomidate

Drug
Who is being recruted

Infections+3

+ Inflammation

+ Pathologic Processes

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorHennepin Healthcare Research Institute
Last updated: May 24, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.

NCT01823328
Principal SponsorHennepin Healthcare Research Institute
Last updated: May 24, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

143 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsis

Criteria

2 inclusion criteria required to participate
18 years of age
Undergoing rapid sequence intubation (RSI) in the Emergency Department
6 exclusion criteria prevent from participating
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
Known contraindication to ketamine or etomidate
Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).

Group II

Active Comparator
Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hennepin County Medical Center

Minneapolis, United StatesOpen Hennepin County Medical Center in Google Maps
CompletedOne Study Center