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

NCT ID: NCT04120870

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-12-30

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.

Conditions

Trauma; Shock, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Etomidate

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

Group Type: ACTIVE_COMPARATOR

Etomidate Injection 0.2 mg/kg

Intervention Type: DRUG

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

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine injection 2 mg/kg

Intervention Type: DRUG

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

Interventions

Etomidate Injection 0.2 mg/kg

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

Intervention Type: DRUG

Ketamine injection 2 mg/kg

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

Intervention Type: DRUG

Other Intervention Names

Etomidate; Ketamine

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unimedics (http://unimedics.co.kr)

UNKNOWN

Sponsor Role: collaborator

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

In-kyong Yi

Clinical assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In Kyong Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou university school of medicine

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

MED-OBS-19-294

Identifier Type: -

Identifier Source: org_study_id