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

Cliniques universitaires Saint Luc0 sites240 target enrollmentNovember 24, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room.
Sponsor: Cliniques universitaires Saint Luc
Enrollment: 240
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

November 24, 2014

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•\-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