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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04120870
• Other study ID #: MED-OBS-19-294
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock, Traumatic
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Etomidate Injection 0.2 mg/kg
The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
• Ketamine injection 2 mg/kg
The induction agent of rapid sequence intubation is ketamine. 2 mg/kg

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (2)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence of hypertension	From injection of induction agent to 20 minutes after, systolic pressure > 160 mmHg defined as hypertension; Patients numbers (%)	25 miinutes