Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil
关键词
抽象
描述
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
日期
| 最后验证: | 10/31/2014 |
| 首次提交: | 02/16/2013 |
| 提交的预估入学人数: | 03/03/2013 |
| 首次发布: | 03/05/2013 |
| 上次提交的更新: | 11/21/2014 |
| 最近更新发布: | 11/24/2014 |
| 实际学习开始日期: | 01/31/2013 |
| 预计主要完成日期: | 02/28/2013 |
| 预计完成日期: | 10/31/2014 |
状况或疾病
干预/治疗
Drug: Xylocain (C)
Drug: Alfentanil Group + Xylocain (A)
Drug: Dexmedetomidine Group + Xylocain (D)
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Xylocain (C) (C): Local anesthesia | Drug: Xylocain (C) Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum |
| Active Comparator: Alfentanil Group + Xylocain (A) Local anesthesia and Alfentanil | Drug: Alfentanil Group + Xylocain (A) (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) |
| Active Comparator: Dexmedetomidine Group + Xylocain (D) Local anesthesia and dexmedetomidine | Drug: Dexmedetomidine Group + Xylocain (D) (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) |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department Exclusion Criteria: - Bronchoscopy outside the endoscopy unit - Tracheal stenosis - SpO2 <90% in the open air - Bradycardia <55 per minute - Atrioventricular block - Heart failure known (EF <40%) - Alcoholism (> 5 drinks per week) |
结果
主要结果指标
1. Bronchoscopy score [At the end of the bronchoscopy procedure]
次要成果指标
1. Level of sedation for bronchoscopy [At the end of the bronchoscopy procedure]
其他成果措施
1. Tolerance of examination [During, at the end and one hour after the bronchoscopy.]
