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临床试验/NCT01792037
NCT01792037已完成4 期

the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
1
主要终点
effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels

研究概览

简要总结

we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 25-65 years old with American Society of Anesthesiology scores III or IV that have applied to emergency department and receives an indication for intubation by the intensive care unit physicians will be included to the study

排除标准

  • Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study.

研究组 & 干预措施

Etomidate

Active Comparator

After taking of the blood samples, patients in Group I will be intubated with 0.3 mg/kg etomidate iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.

干预措施: Etomidate (Drug)

etomidate, steroid

Active Comparator

After taking of the blood samples, patients in Group II will be intubated with 0.3 mg/kg etomidate iv following a 2mg/kg methylprednisolone iv Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.

干预措施: Etomidate (Drug)

etomidate, steroid

Active Comparator

After taking of the blood samples, patients in Group II will be intubated with 0.3 mg/kg etomidate iv following a 2mg/kg methylprednisolone iv Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.

干预措施: methylprednisolone (Drug)

midazolam

Active Comparator

After taking of the blood samples, patients in Group III will be intubated with 0.01 mg/kg midazolam iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.

Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.

干预措施: Midazolam (Drug)

结局指标

主要结局

effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels

时间窗: 24 hours

次要结局

  • compare effects of midazolam and etomidate on systemic blood pressure(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guniz M.Koksal

Assoc.Prof.

Istanbul University

研究点 (1)

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