Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil
Condition: Bronchoscopy; Conscious Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      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:

        1. - Group standard/control: local anesthesia only(C)

        2. - Group alfentanil + local anesthesia(A)

        3. - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy
           score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy
           examination. Measured parameters on the safety of examination are: the lowest
           saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and
           if the patient is ready or not to undertake bronchoscopy second time in his life if
           necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen
           are collected every 5 minutes before, during and after the bronchoscopy.
    

Detailed description: 
      BACKGROUND:

        1. 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].

        2. 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:

        -  Group standard / control (local anesthesia only): (C)

        -  Group alfentanil (+ local anesthesia): (A)

        -  Group dexmedetomidine (+ local anesthesia): (D)

      The primary endpoint is:

        1. / Feasibility / tolerance of bronchoscopy by the "score bronchoscopy" which includes:

             -  The movement of the vocal cords (4 levels)

             -  Cough (4 levels)

             -  Movement members (4 levels)

           Secondary objectives:

        2. / level sedation for bronchoscopy:

             -  Level of sedation achieved according to the objective using: Nursing Instrument for
                the Communication of Sedation (NICS) (7 levels).

             -  Dose of midazolam necessary complementary in each group. Midazolam to give to the
                judgment of the operator (if necessary) is predetermined speed (1 mg each minute)
                to the level of sedation (-1) "Level of sedation achieved according to the
                objective using: Nursing Instrument for the communication of Sedation (NICS)".

        3. / Tolerance examination:

             -  During the procedure

             -  At the end of the procedure

             -  After 1 hour of the end of the examination
    

Intervention name(s): xylocain; Alfentanil; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum; (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); (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)
Other intervention name(s): Xylocain only; Alfentanil as morphinics short acting; Dexmedetomidine as awake sedation
Intervention MeSH terms: Dexmedetomidine; Alfentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchoscopy; sedation; pulmonary function; tolerance; xylocain; dexmedetomidine; alfentanil