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

NCT01698892 | Terminated Phase 4 DMC

• 1 other identifier: RC12_0208
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Keywords

I.V. sedation, midazolam, bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Intensity of dyspnea

  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).

  1 day

Secondary Outcomes (7)

• VAS Individual scores

  1 day

• Blood pressure

  1 day

• Desaturation frequency

  1 day

• heart rate

  1 day

• OAAS Score

  1 day

Study Arms (2)

I.V. sedation

EXPERIMENTAL

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

Drug: I.V Sedation

sublingual sedation

ACTIVE COMPARATOR

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

Drug: sublingual sedation

Interventions

I.V Sedation DRUG

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

I.V. sedation

sublingual sedation DRUG

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

sublingual sedation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating, women
• PAH patients
• patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy
• Patients with oral anticoagulants

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Cavailles

Nantes, 44000, France

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 18, 2023

Record last verified: 2015-06

Locations

FR (1)