Sedation During Bronchoscopy
Conditions
Keywords
I.V. sedation, midazolam, bronchoscopy
Brief summary
Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic procedures. Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous. We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy
Interventions
DRUGI.V Sedation
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group
DRUGsublingual sedation
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men or women aged between 18 and 80, who will undergo bronchoscopy * FEV1≥ 50% of theorical value * Ambient air saturation at rest ≥ 94% * No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound * fasting for at least 6 hours * No indication against bronchoscopy, nor to premedication * Informed consent signed
Exclusion criteria
* Pregnant or lactating, women * PAH patients * patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy * Patients with oral anticoagulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of dyspnea | 1 day | Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Individual scores | 1 day | VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance) |
| Blood pressure | 1 day | Blood pressure (mean blood pressure measurements made before, during and after the exam) |
| Desaturation frequency | 1 day | Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90% |
| OAAS Score | 1 day | OAAS Score after bronchoscopy |
| Bronchoscopy duration | 1 day | Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy) |
| Comparison of midazolam total dose | 1 day | Comparison of midazolam total dose administered in each group |
| heart rate | 1 day | Initial and maximum heart rate during bronchoscopy (continuous monitoring) |
Countries
France
Outcome results
None listed