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The purpose of this study is to find the best sedation necessary for patients undergoing bronchoscopy. Patients are randomized to three different regimes of sedation during bronchoscopy were studied:
BACKGROUND:
Problem:
The endoscopy of the tracheobronchial tree by endoscopy is an act very common in the daily activity of pulmonologists. The indications for bronchoscopy are multiple and include infectious causes, tumor, systemic disease, foreign bodies and other indications. It can be diagnostic or therapeutic purposes. Bronchoscopy is an invasive but rarely, however, induced severe complications (respiratory failure, hemodynamic collapse, massive bleeding ...). However, tolerance to the examination varies significantly between patients [1-3]. Different signs and symptoms include desaturation, chest pain, choking sensation and cough. These effects are likely to alter patient comfort during the procedure and the quality of it. To further improve the tolerance operators have resorted to various techniques. A first step in improving the comfort is a good local anesthesia using spray or swab intra nasal base and lidocaine anesthesia of the airway (trachea, carina and bronchi) during the examination. The second step involves the use of intravenous sedation [1, 3-14].
Background:
Until now, there is no standardized protocol for the best product and the best dose to use for sedation of patients. Several studies have been done comparing different drug or drug combination in the benzodiazepine family, ketamine or morphine with varying results and not leading in most cases to allow conclusions to establish clear guidelines regarding the use or no sedation plus local anesthesia and sedation dose of this [1, 3, 5, 8, 15]. Especially, for fear of adverse effects of sedation on respiratory function, many pulmonologists far are a little hesitant about the administration of sedatives during bronchoscopy. Dexmedetomidine is a new molecule sedation which is approved for its sedative effect while holding a revival meeting described as "awake sedation." [12, 16-22]
DESCRIPTION:
The aim of this randomized controlled trial was to evaluate the feasibility and safety of three different regimes of sedation during bronchoscopy:
The primary endpoint is:
/ Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:
Secondary objectives:
/ level sedation for bronchoscopy:
/ Tolerance examination:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylocain (C) | Placebo Comparator | (C): Local anesthesia |
|
| Alfentanil Group + Xylocain (A) | Active Comparator | Local anesthesia and Alfentanil |
|
| Dexmedetomidine Group + Xylocain (D) | Active Comparator | Local anesthesia and dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xylocain | Drug | Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoscopy score | Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:
| At the end of the bronchoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Level of sedation for bronchoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of examination | Visual Analogic Scale from 0-10 to evaluate the tolerance of the procedure:
| During, at the end and one hour after the bronchoscopy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moussa A Riachy, MD, FCCP | Saint-Joseph University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de France Hospital | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Alfentanil | Drug | (A) Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum (slow perfusion for 10 minutes) + alfentanil 10 mcg / kg (slow injection in 5 seconds) |
|
|
| Dexmedetomidine | Drug | (D) Local anesthesia 1% 25 ml in total (bronchoscopy) + dexmedetomidine 0.5 mcg / kg (slow perfusion for 10 minutes) + 2 ml saline (slow injection for 5 seconds) |
|
|
| At the end of the bronchoscopy procedure |
| D007093 |
| Imidazoles |
| D001393 | Azoles |