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临床试验/NCT01805726
NCT01805726已完成3 期

Success of Sedation During Bronchoscopy: Comparison of the Effects of Dexmedetomidine, Alfentanil and Local Anesthesia

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
162
试验地点
1
主要终点
Bronchoscopy score

研究概览

简要总结

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:

    • Group standard/control: local anesthesia only(C)
    • Group alfentanil + local anesthesia(A)
    • 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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department

排除标准

  • 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)

研究组 & 干预措施

Xylocain (C)

Placebo Comparator

(C): Local anesthesia

干预措施: xylocain (Drug)

Alfentanil Group + Xylocain (A)

Active Comparator

Local anesthesia and Alfentanil

干预措施: Alfentanil (Drug)

Dexmedetomidine Group + Xylocain (D)

Active Comparator

Local anesthesia and dexmedetomidine

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Bronchoscopy score

时间窗: At the end of the bronchoscopy procedure

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) Scale will be between: minimum 3 and maximum 16

次要结局

  • Level of sedation for bronchoscopy(At the end of the bronchoscopy procedure)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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