Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

Study Overview
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Brief Summary
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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.

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

Conditions
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Procedural Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Alfentanil


Participation Criteria
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Eligibility Criteria
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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 : Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine and Alfentanil<br>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. | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;Drug: Alfentanil<br> <br> * Other names: Rapifen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ramsay score scale |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep sedation, Dexmedetomidine, Emergency Service, Hospital