Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
Phase 4
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Both
Sedation During Bronchoscopy
Both
Sedation During Bronchoscopy
Trial Information
Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Intensity of dyspnea
Outcome Description:
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).
Outcome Time Frame:
1 day
Safety Issue:
No
Authority:
France : ANSM
Study ID:
12_0208
NCT ID:
NCT01698892
Start Date:
October 2012
Completion Date:
October 2013
Related Keywords:
- Sedation During Bronchoscopy
- I.V. sedation, midazolam, bronchoscopy
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