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

Primary Purpose

Trauma, Shock, Traumatic

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Etomidate Injection 0.2 mg/kg
Ketamine injection 2 mg/kg
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trauma focused on measuring etomidate, ketamine, rapid sequence intubation, trauma, hemodynamics

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou university school of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Etomidate

Ketamine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2019
Last Updated
February 16, 2022
Sponsor
Ajou University School of Medicine
Collaborators
Unimedics (http://unimedics.co.kr)
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1. Study Identification

Unique Protocol Identification Number
NCT04120870
Brief Title
Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients
Official Title
Comparison of Effects on Hemodynamics Between Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients With High Shock Index
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to difficulties in obtaining consent because of emergency situation
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Unimedics (http://unimedics.co.kr)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Shock, Traumatic
Keywords
etomidate, ketamine, rapid sequence intubation, trauma, hemodynamics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
open label
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etomidate
Arm Type
Active Comparator
Arm Description
The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
Intervention Type
Drug
Intervention Name(s)
Etomidate Injection 0.2 mg/kg
Other Intervention Name(s)
Etomidate
Intervention Description
The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
Intervention Type
Drug
Intervention Name(s)
Ketamine injection 2 mg/kg
Other Intervention Name(s)
Ketamine
Intervention Description
The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
Primary Outcome Measure Information:
Title
Systolic blood pressure difference compared with baseline after 10 minutes
Description
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 Outcome Measure Information:
Title
Intubating condition
Description
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
Title
Incidence of hypotension
Description
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 (%)
Time Frame
25 minutes
Title
Incidence of hypertension
Description
From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension Patients numbers (%)
Time Frame
25 miinutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Kyong Yi, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou university school of medicine
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If there is a reasonable request, we can share the data personally.

Learn more about this trial

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

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