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

NCT04120870 | Terminated

• 1 other identifier: MED-OBS-19-294
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trauma; Shock, Traumatic

Keywords

etomidate; ketamine; rapid sequence intubation; trauma; hemodynamics

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure difference compared with baseline after 10 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.

  13 minutes

Secondary Outcomes (3)

• Intubating condition

  5 minutes

• Incidence of hypotension

  25 minutes

• Incidence of hypertension

  25 miinutes

Study Arms (2)

Etomidate

ACTIVE COMPARATOR

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

Drug: Etomidate Injection 0.2 mg/kg

Ketamine

EXPERIMENTAL

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

Drug: Ketamine injection 2 mg/kg

Interventions

Etomidate Injection 0.2 mg/kg DRUG

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

Also known as: Etomidate

Etomidate

Ketamine injection 2 mg/kg DRUG

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

Also known as: Ketamine

Ketamine

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Unimedics (http://unimedics.co.kr): collaborator

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Wounds and Injuries; Shock, Traumatic

Interventions

Etomidate; Ketamine

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• In Kyong Yi, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 9, 2019
• Study Start: October 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)