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

Not Applicable

Terminated

• Conditions: Trauma; Shock, Traumatic
• Interventions: Drug: Etomidate Injection 0.2 mg/kg; Drug: Ketamine injection 2 mg/kg

• Registration Number: NCT04120870
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study Start: 2019-10-01
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate	Etomidate Injection 0.2 mg/kg	The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
Ketamine	Ketamine injection 2 mg/kg	The induction agent of rapid sequence intubation is ketamine. 2 mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%)
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 hypertension	25 miinutes	From injection of induction agent to 20 minutes after, systolic pressure \> 160 mmHg defined as hypertension; Patients numbers (%)

Trial Locations

Locations (1)

Ajou university school of medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of