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End study
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I.V. sedation | Experimental | Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation |
|
| sublingual sedation | Active Comparator | Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I.V Sedation | Drug | Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of dyspnea | 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). | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Individual scores | VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance) | 1 day |
| Blood pressure | Blood pressure (mean blood pressure measurements made before, during and after the exam) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cavailles | Nantes | 44000 | France |
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| sublingual sedation | Drug | Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group |
|
| 1 day |
| Desaturation frequency | Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90% | 1 day |
| heart rate | Initial and maximum heart rate during bronchoscopy (continuous monitoring) | 1 day |
| OAAS Score | OAAS Score after bronchoscopy | 1 day |
| Bronchoscopy duration | Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy) | 1 day |
| Comparison of midazolam total dose | Comparison of midazolam total dose administered in each group | 1 day |