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

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

Detailed Description
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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.

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

Conditions
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Trauma, Shock, Traumatic

Intervention / Treatment
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* Drug: Etomidate Injection 0.2 mg/kg
* Drug: Ketamine injection 2 mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etomidate<br>The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg | Drug: Etomidate Injection 0.2 mg/kg<br>* The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg<br>* Other names: Etomidate;|
| Experimental: Ketamine<br>The induction agent of rapid sequence intubation is ketamine. 2 mg/kg | Drug: Ketamine injection 2 mg/kg<br>* The induction agent of rapid sequence intubation is ketamine. 2 mg/kg<br>* Other names: Ketamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubating condition | 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. | 5 minutes | 
| Incidence of hypotension | 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 Patient numbers (%) | 25 minutes | 
| Incidence of hypertension | From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension Patients numbers (%) | 25 miinutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etomidate, ketamine, rapid sequence intubation, trauma, hemodynamics