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

N/ATerminatedNCT04120870

Ajou University School of Medicine10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Trauma Shock, Traumatic

Interventions

Etomidate Injection 0.2 mg/kgDRUG

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

Ketamine injection 2 mg/kgDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 13 minutes

Secondary Outcomes

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".

Time frame: 5 minutes

Incidence of hypotension

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 (%)

Time frame: 25 minutes

Incidence of hypertension

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

Time frame: 25 miinutes

Data from ClinicalTrials.gov

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