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

Sedation During Bronchoscopy Clinical Trial

— TORSIV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01698892
• Other study ID #: RC12_0208
• Status: Terminated
• Phase: Phase 4
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation During Bronchoscopy

Intervention

Drug:
• I.V Sedation
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

Locations

Country	Name	City	State
France	Cavailles	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	VAS Individual scores	VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)	1 day
Secondary	Blood pressure	Blood pressure (mean blood pressure measurements made before, during and after the exam)	1 day
Secondary	Desaturation frequency	Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%	1 day
Secondary	heart rate	Initial and maximum heart rate during bronchoscopy (continuous monitoring)	1 day
Secondary	OAAS Score	OAAS Score after bronchoscopy	1 day
Secondary	Bronchoscopy duration	Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)	1 day
Secondary	Comparison of midazolam total dose	Comparison of midazolam total dose administered in each group	1 day