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?
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
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