Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?

Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 sites40 target enrollmentFebruary 2015

Overview

Brief Summary

The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.

Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.

Patients will also receive a dose of alfentanil, 1 minute before the technical act.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•The insertion of a chest drain
•Abscess incision and drainage
•Closed reduction of a dislocated joint

Exclusion Criteria

•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
•The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
•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 \< 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg
•Patients with contraindication to the use of dexmedetomidine :

Arms & Interventions

Dexmedetomidine and Alfentanil

Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine. At time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes. Patients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes. Afterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine Patients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act. A new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN \> 50. The maximum dose of alfentanil the patient can receive is 5 mcg / kg.

Intervention: Dexmedetomidine

Dexmedetomidine and Alfentanil

Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine. At time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes. Patients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes. Afterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine Patients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act. A new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN \> 50. The maximum dose of alfentanil the patient can receive is 5 mcg / kg.

Intervention: Alfentanil