Can we get conscious sedation in optimal safety conditions in an emergency department, by combining dexmedetomidine with alfentanil?
- Conditions
- Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room.Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2014-005170-11-BE
- Lead Sponsor
- Cliniques universitaires Saint Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method