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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine and Alfentanil | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ramsay score scale | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 2 hours |
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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:
Exclusion Criteria:
Respiratory rate > 30 / min Oxygen saturation <90%
A heart rate > 120 / min A heart rate < 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg
Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease
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| Name | Affiliation | Role |
|---|---|---|
| Franck Verschuren, MD, PhD | St Luc | Principal Investigator |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Alfentanil |
| Drug |
|
|
| D005283 |
| Fentanyl |
| D010880 | Piperidines |