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

NCT ID: NCT01698892

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-12-31

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

Conditions

Sedation During Bronchoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

I.V. sedation

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

Group Type: EXPERIMENTAL

I.V Sedation

Intervention Type: DRUG

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

sublingual sedation

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

Group Type: ACTIVE_COMPARATOR

sublingual sedation

Intervention Type: DRUG

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

Interventions

I.V Sedation

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

Intervention Type: DRUG

sublingual sedation

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cavailles

Nantes, , France

Countries

France

Other Identifiers

RC12_0208

Identifier Type: -

Identifier Source: org_study_id