Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.

RC12_0208

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

2012-10-01

2014-12-01

2014-12-01

Terminated

Early phase I

85

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 85, 'type': 'ACTUAL'}}

2023-11-18