Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients

Overview

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

Full Title of Study: “Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

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.

Interventions

  • Drug: Etomidate Injection 0.2 mg/kg
    • The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
  • Drug: Ketamine injection 2 mg/kg
    • The induction agent of rapid sequence intubation is ketamine. 2 mg/kg

Arms, Groups and Cohorts

  • Active Comparator: Etomidate
    • The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
  • Experimental: Ketamine
    • The induction agent of rapid sequence intubation is ketamine. 2 mg/kg

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Intubating condition
    • Time Frame: 5 minutes
    • Intubator judge intubating condition Laryngoscopy: easy / fair / difficult Vocal cords position: abducted / moving / closed Reaction to insertion of the tracheal tube and cuff inflation : none / slight / vigorous
  • Incidence of hypotension
    • Time Frame: 25 minutes
    • If any of these are checked, define as hypotension (from injection of induction agent to 20 minutes after) systolic pressure < 90 mmHg systolic pressure decrease > 40% compared to baseline Initiation of vasopressor Vasopressor dose increase > 30% of initial vaopressor dose Fluid or blood loading
  • Incidence of hypertension
    • Time Frame: 25 miinutes
    • From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ajou University School of Medicine
  • Collaborator
    • Unimedics (http://unimedics.co.kr)
  • Provider of Information About this Clinical Study
    • Principal Investigator: In-kyong Yi, Clinical assistant professor – Ajou University School of Medicine
  • Overall Official(s)
    • In Kyong Yi, MD, Principal Investigator, Ajou University School of Medicine
  • Overall Contact(s)
    • In Kyong Yi, MD, +82-31-219-7522, lyrin01@gmail.com

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