跳至主要内容
临床试验/EUCTR2014-005170-11-BE
EUCTR2014-005170-11-BE进行中(未招募)1 期

Can we get conscious sedation in optimal safety conditions in an emergency department, by combining dexmedetomidine with alfentanil?

Cliniques universitaires Saint Luc0 个研究点目标入组 240 人开始时间: 2014年11月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:
  • Insertion of a chest drain
  • Abscess incision and drainage
  • Electrical cardio version
  • Closed reduction of a dislocated joint
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 140
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • -Patients refusing to participate in the study (refusal to sign the consent form)
  • -Patients refusing sedation
  • -Patients unable to participate in the study (consent is impossible to obtain)
  • -Pregnant women
  • -Patients with poor respiratory status determined by :
  • Respiratory rate > 30 / min
  • Oxygen saturation <90%
  • - Patients with unfavorable hemodynamic status determined by :
  • A heart rate > 120 / min
  • A heart rate < 45 / min
  • Systolic blood pressure = 180 mmHg or =100mmHg
  • Diastolic blood pressure = 110mmHg
  • - Patients with contraindication to the use of dexmedetomidine :
  • Advanced heart block (level 2 or 3) unless pacemaker
  • Acute cerebrovascular disease

研究者

相似试验