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Clinical Trials/NCT04120870
NCT04120870TerminatedNot Applicable

Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index

Ajou University School of Medicine1 site in 1 country10 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Systolic blood pressure difference compared with baseline after 10 minutes

Study Overview

Brief Summary

In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.

Detailed Description

In trauma patients, rapid sequence intubation is recommended. The drug of choice, however, has been debated. One cohort comparative study showed ketamine had benefit in hemodynamics compared to etomidate in trauma patients. One observational study showed in high shock index patients, ketamine showed maintain systolic blood pressure. And other retrospective showed less clinical hypotension was less in ketamine. However there is no randomized controlled study comparing ketamine and etomidate in trauma patients. The purpose of this study is comparing the effects of hemodynamics between ketamine and etomidate in high shock index trauma patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Masking Description

open label

Eligibility Criteria

Ages
19 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age 19~70
  • Shock index ≥ 0.9
  • Patients who need intubation regarding to Ajou trauma center protocol

Exclusion Criteria

  • during CPR
  • CPR before hospital arrival
  • Severe head trauma
  • Steroid intake history

Arms & Interventions

Etomidate

Active Comparator

The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg

Intervention: Etomidate Injection 0.2 mg/kg (Drug)

Ketamine

Experimental

The induction agent of rapid sequence intubation is ketamine. 2 mg/kg

Intervention: Ketamine injection 2 mg/kg (Drug)

Outcomes

Primary Outcomes

Systolic blood pressure difference compared with baseline after 10 minutes

Time Frame: 13 minutes

Systolic blood pressure 10 minutes after induction agent injection - baseline systolic blood pressure mmHg Positive or zero value means good result. Negative value means poor result.

Secondary Outcomes

  • Incidence of hypotension(25 minutes)
  • Intubating condition(5 minutes)
  • Incidence of hypertension(25 miinutes)

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

In-kyong Yi

Clinical assistant professor

Ajou University School of Medicine

Study Sites (1)

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