Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Nantes University Hospital
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Intensity of dyspnea
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
I.V. sedation
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation
Intervention: I.V Sedation (Drug)
sublingual sedation
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
Intervention: sublingual sedation (Drug)
Outcomes
Primary Outcomes
Intensity of dyspnea
Time Frame: 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 Outcomes
- OAAS Score(1 day)
- VAS Individual scores(1 day)
- Bronchoscopy duration(1 day)
- Blood pressure(1 day)
- Desaturation frequency(1 day)
- heart rate(1 day)
- Comparison of midazolam total dose(1 day)