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

Ketamine

Brief Summary

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

Intervention / Treatment

ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
  • Etomidate Injection 0.2 mg/kg (DRUG)
    The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
  • Ketamine injection 2 mg/kg (DRUG)
    The induction agent of rapid sequence intubation is ketamine. 2 mg/kg

Condition or Disease

  • Trauma
  • Shock, Traumatic

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 19 Years to 70 Years
    Enrollment: 10 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    Open label

    Clinical Trial Dates

    Start date: Oct 01, 2019 ACTUAL
    Primary Completion: Nov 30, 2021 ACTUAL
    Completion Date: Dec 30, 2021 ACTUAL
    Study First Posted: Oct 09, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 16, 2022

    Sponsors / Collaborators

    Lead Sponsor: Ajou University School of Medicine
    Responsible Party: N/A

    Location

    South Korea
    Gyeong-gi Do, South Korea

    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.

    Participant Groups

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 19
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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

    • Intubator judge intubating condition Laryngoscopy: easy / fair / difficult (difficult is the worst result) Vocal cords position: abducted / moving / closed (closed is the worst result) Reaction to insertion of the tracheal tube and cuff inflation : none / slight / vigorous (none is the worst result) If one of category checked the worst score, it considered :clinically unacceptable".

    • If any of these are checked, define as hypotension (from injection of induction agent to 20 minutes after) 1. systolic pressure \< 90 mmHg 2. systolic pressure decrease \> 40% compared to baseline 3. Initiation of vasopressor 4. Vasopressor dose increase \> 30% of initial vaopressor dose 5. Fluid or blood loading Patient numbers (%)

    • From injection of induction agent to 20 minutes after, systolic pressure \> 160 mmHg defined as hypertension Patients numbers (%)

    More Details

    NCT Number: NCT04120870
    Other IDs: MED-OBS-19-294
    Study URL: https://clinicaltrials.gov/study/NCT04120870
    Last updated: Sep 29, 2023