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临床试验/NCT04120870
NCT04120870终止不适用

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

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
1
主要终点
Systolic blood pressure difference compared with baseline after 10 minutes

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

open label

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 19~70
  • Shock index ≥ 0.9
  • Patients who need intubation regarding to Ajou trauma center protocol

排除标准

  • during CPR
  • CPR before hospital arrival
  • Severe head trauma
  • Steroid intake history

研究组 & 干预措施

Etomidate

Active Comparator

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

干预措施: Etomidate Injection 0.2 mg/kg (Drug)

Ketamine

Experimental

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

干预措施: Ketamine injection 2 mg/kg (Drug)

结局指标

主要结局

Systolic blood pressure difference compared with baseline after 10 minutes

时间窗: 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.

次要结局

  • Incidence of hypotension(25 minutes)
  • Intubating condition(5 minutes)
  • Incidence of hypertension(25 miinutes)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

In-kyong Yi

Clinical assistant professor

Ajou University School of Medicine

研究点 (1)

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