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

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

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

Study Overview

• Status: Terminated
• Conditions: Trauma; Shock, Traumatic
• Intervention / Treatment: Drug: Etomidate Injection 0.2 mg/kg; Drug: Ketamine injection 2 mg/kg

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: trauma; ketamine; hemodynamics; etomidate; rapid sequence intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Wounds and Injuries; Shock, Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Etomidate
• Other Study ID Numbers: MED-OBS-19-294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: If there is a reasonable request, we can share the data personally.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No