Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.

NCT ID: NCT03703960

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2022-04-25

Brief 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

Patient With Bronchial Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1 "Hypnosis"

Group Type: EXPERIMENTAL

hypnotic analgesia

Intervention Type: OTHER

classic three-step hypnosis procedure (induction, trance and return to consciousness).

Group 2 "music"

Group Type: ACTIVE_COMPARATOR

music

Intervention Type: OTHER

calm music conducive to relaxation

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

hypnotic analgesia

classic three-step hypnosis procedure (induction, trance and return to consciousness).

Intervention Type: OTHER

music

calm music conducive to relaxation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Minor
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

GEORGES ADEMPU 2018

Identifier Type: -

Identifier Source: org_study_id