跳至主要内容
临床试验/NCT03703960
NCT03703960终止不适用

Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
49
试验地点
2
主要终点
score for the sensory component of dyspnea

研究概览

简要总结

Bronchial endoscopy (or bronchial fibroscopy) is an invasive diagnostic examination performed extremely frequently in the Pneumology department of the Dijon University Hospital, with an average of 1200 procedures per year. It allows the pneumologist to see the first divisions of the bronchial tree but also to take samples for microbiological or anatomopathological purposes. The two main sampling techniques are bronchoalveolar lavage and endobronchial biopsies. Two steps in the process can be unpleasant for the patient:

  1. the crossing of the nasopharynx because of the narrow and curving passage,
  2. the crossing of the vocal cords and exploration of the trachea, which sometimes causes nausea but especially a cough and a feeling of suffocation.

Depending on the patients, the experience of the examination can be very difficult. In addition, the experience of the examination is influenced by the psychological state of the patient, who is often anxious in the perspective of a diagnosis of a malignancy. It is therefore recommended to perform this examination under local anesthesia (LA) with xylocaine spray 5%. Several protocols, such as the use of atropine, hydroxyzine or benzodiazepines, have been proposed to improve test tolerance, but no pre-medication, other than the drugs indicated in general anesthesia, including midazolam and propofol, has demonstrated their efficacy. Moreover, these molecules are not without respiratory side effects.

Several recent studies have suggested that hypnotic analgesia improves the experience and course of diagnostic procedures that are quite similar to bronchial endoscopy and are usually performed with LA. This is particularly the case for gastroscopy or trans-oesophageal ultrasound. In addition, the effectiveness of hypnotic analgesia for the relief of acute or chronic pain is increasingly well established in the literature. However, the pathophysiology of dyspnea is close to that of pain.

The hypothesis is that adding hypnotic analgesia to the usual local anesthesia will relieve the dyspnea and pain experienced during the examination. There are no studies or data yet on the effect of hypnotic analgesia in bronchial endoscopy with LA. The objective of this work is to demonstrate its effectiveness in order to potentially offer this intervention to all patients and to improve the management of this procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Person who has given oral consent
  • Patient having:
  • a bronchial endoscopy for diagnostic purposes,
  • performed on schedule in the Pneumology Department and Intensive Respiratory Care at the Dijon University Hospital
  • regardless of the indication or samples taken during the examination (simple exploration, lavage, biopsies)

排除标准

  • Person not affiliated to a national health insurance system
  • Person subject to legal protection (curatorship, guardianship)
  • Person under judiciary protection
  • Non-menopausal woman
  • Adult unable or unwilling to consent
  • Patient who does not speak French
  • Patient with severe hearing disorder that make it difficult to perform hypnosis under good conditions
  • Patient with psychiatric or neurological disorders such as dementia, psychosis or profound mental retardation
  • Severe COPD requiring long-term oxygen therapy at home or with a tracheotomy
  • Patient undergoing bronchial endoscopy for the management of acute respiratory distress

结局指标

主要结局

score for the sensory component of dyspnea

时间窗: through study completion, an average of 30 minutes

Comparison of the evolution of the score assigned to the sensory component of dyspnea measured by the Multidimensional Dyspnea Profile (MDP) scale before and after bronchial endoscopy between patients of the interventional arm 1 under local anesthesia and hypnotic analgesia, patients of the interventional arm 2 under local anesthesia and relaxing music and patients of the control arm under LA bronchial endoscopy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验