Clinical Trials Directory

Trials / Terminated

TerminatedNCT03703960

Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERhypnotic analgesiaclassic three-step hypnosis procedure (induction, trance and return to consciousness).
OTHERmusiccalm music conducive to relaxation

Timeline

Start date
2018-12-10
Primary completion
2022-04-25
Completion
2022-04-25
First posted
2018-10-12
Last updated
2023-09-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03703960. Inclusion in this directory is not an endorsement.