Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room.
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexdor
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Rapifen
Product Name: Rapifen
Pharmaceutical Form: Solution for injection
Sponsors
Cliniques universitaires Saint Luc
Eligibility
Sex/Gender
All
Inclusion 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: • 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
Exclusion criteria
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 -Patients with poor respiratory status determined by : Respiratory rate > 30 / min Oxygen saturation 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to determine if combinaison of dexmédétomidine and alfentanil allows a level of conscious sedation within maximum security conditions in an emergency department.;Secondary Objective: 1. Check the relation between the patient's level of anxiety and the drugs (dexmédétomidine and l’alfentanil) quality of response 2.Determine the requested total dose of dexmédétomidine to obtain a level of sedation corresponding to the Ramsey score 2-3 3. Determine the requested time in minutes to reach the Ramsey score 2-3 4.Determine the requested total dose of alfentanil to reach a good level of analgesia 5.Observe the evolution of the pain score durring the procedure. It will be evaluated before and after the procedure with the numerical scale. 6.Observe the evolution of the patient's anxiety before and after the treatment 7. Compared the results with the « Assessment of Alertness/Sedation (OAA/S) scale » and those obtained by the Ramsay score assessment as well as to the modification of the bispectral index during the sedation;Primary end point(s): 1. Can we obtain an adequate level of sedation with dexmedetomidine and alfentanyl in an emergency department? The Ramsay score scale will evaluate the sedation level The objective is to reach a score of 2 or 3 on the Ramsay score scale 2. Can we do a procedural sedation with dexmedetomidine in optimal safety conditions in an emergency department? The optimal safety conditions are determined by: 1. A stable blood pressure 2. A stable heart rhythm 3. No respiratory depression 4. Absence of hypoxia 5. Absence of vomiting ;Timepoint(s) of evaluation of this end point: The monitoring of the cardiovascular functions, the respiratory status and the sedation level will be performed as follows: Continually: for heart rate, oxygen saturation and EtCO2 Every 3 min : for blood pressure and respiratory frequency Every 5 min : for Ramsay sedation score , the OAAS and BIS The observation of the change | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Wich dose of dexmedetomidine is needed to obtain the adequate sedation? 2. How long do we need to obtain adequate sedation? 3. Which dose of alfentanil do we need to obtain the adequate analgesia? 4. Evolution of patient’s pain will be assessed during the procedure. It will be evaluated before and after the procedure using the numerical scale 5. Evolution of patient’s pain will be assessed before and after the treatment of the combination dexmedetomidine – alfentanil 6. A comparison will be made between changes in the bispectral index (BIS) during sedation with the results obtained by the scale of sedation " Assessment of Alertness / Sedation (OAA / S) scale " and those obtained by the Ramsay score scale ;Timepoint(s) of evaluation of this end point: The monitoring of the cardiovascular functions, the respiratory status and the sedation level will be performed as follows: Continually: for heart rate, oxygen saturation and EtCO2 Every 3 min : for blood pressure and respiratory frequency Every 5 min : for Ramsay sedation score , the OAAS and BIS The observation of the change of the « Pleth Variability Index » The level of anxiety and pain will be evaluated before and after the procedure. The level of pain will be evaluated by a numerical scale (EN). The level of anxiety of the patient will be assessed by quantification of anxiety on a VAS scale. | — |
Countries
Belgium
Contacts
Public ContactCUSL
Cliniques universitaires Saint-Luc
Outcome results
None listed