Shock, Traumatic, Trauma
Conditions
Keywords
etomidate, ketamine, rapid sequence intubation, trauma, hemodynamics
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.
Interventions
DRUGEtomidate Injection 0.2 mg/kg
The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
DRUGKetamine injection 2 mg/kg
The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
Sponsors
Unimedics (http://unimedics.co.kr)
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
open label
Intervention model description
ketamine group: ketamine 2 mg/kg iv as induction agent etomidate group: etomidate 0.2 mg/kg iv as induction agent
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure difference compared with baseline after 10 minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Intubating condition | 5 minutes | 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. |
| Incidence of hypotension | 25 minutes | 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 (%) |
| Incidence of hypertension | 25 miinutes | From injection of induction agent to 20 minutes after, systolic pressure \> 160 mmHg defined as hypertension Patients numbers (%) |
Countries
South Korea
Outcome results
None listed