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

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 4

Conditions: Sedation During Bronchoscopy

Treatments: Drug: sublingual sedation; Drug: I.V Sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT01698892

RC12_0208

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

85 participants in 2 patient groups

I.V. sedation

Experimental group

Description:

Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation

Treatment:

Drug: I.V Sedation

sublingual sedation

Active Comparator group

Description:

Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group

Treatment:

Drug: sublingual sedation