跳至主要内容
临床试验/NCT01854515
NCT01854515Unknown不适用

Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients

Saeed Abbasi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
post extubation stridor

研究概览

简要总结

The present study was aimed at investigating the efficacy of nebulizing Budesonide sin comparison with intravenous Dexamethasone before extubation in prevention of post-extubation complications amongst patients admitted in intensive care unit.

In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.

The investigators divide our patients randomly into two equal groups.

-In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose of 1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After extubation patients received nebulizing budesonide via oxygen mask at the same dose every 12 hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered to patient at a dose of 0.15 mg/kg before extubation. After extubation, the administration of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.

Another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients' age 18-65 years old
  • Intubated for more than 48 hours after surgery
  • Met the weaning criteria defined as respiratory rate < 30 breaths / min, negative tidal volume > 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) < 105 breaths / min/L

排除标准

  • Any history of corticosteroid therapy in previous week
  • Nasal or throat disease / surgery
  • Pulmonary airway disease
  • Gastrointestinal bleeding

研究组 & 干预措施

Budesonide

Active Comparator

1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After extubation patients received nebulizing Budesonide via oxygen mask at the same dose every 12 h. for 48 h.

干预措施: Budesonide (Drug)

Dexamethasone

Experimental

0.15 mg/kg before extubation. After extubation, the administration of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.

干预措施: Dexamethasone acetate (Drug)

结局指标

主要结局

post extubation stridor

时间窗: After extubation until 48 hours

Until 48 hours after extubation we documented if there is stridor in examination

次要结局

未报告次要终点

研究者

发起方
Saeed Abbasi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Saeed Abbasi

Assistant Professor in Anesthesiology

Isfahan University of Medical Sciences

研究点 (1)

Loading locations...

相似试验